NA (Page 15 of 15)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Duloxetine Delayed-Release Capsules USP, 20 mg are available as opaque light blue body and opaque light blue cap with white markings of 0012 on the cap and 20 mg on the body:
• Bottles of 60 NDC 70247-012-06

Duloxetine Delayed-Release Capsules USP, 30 mg are available as opaque white body and opaque blue cap with black markings of 0013 on the cap and 30 mg on the body:
• Bottles of 30 NDC 70247-013-03
•� Bottles of 90 NDC 70247-013-09
• Bottles of 1000 NDC 70247-013-10

Duloxetine Delayed-Release Capsules USP, 60 mg are available as opaque light blue body and opaque blue cap with white markings of 0014 on the cap and 60 mg on the body:
• Bottles of 30 NDC 70247-014-03
• Bottles of 60 NDC 70247-014-06
• Bottles of 500 NDC 70247-014-50

16.2 Storage and Handling

Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in tightly closed container.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling ( Medication Guide).

  • Information on Medication Guide — Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with duloxetine delayed-release capsules and counsel them in its appropriate use. A patient Medication Guide is available for duloxetine delayed-release capsules. Instruct patients, their families, and their caregivers to read the Medication Guide before starting duloxetine delayed-release capsules and each time their prescription is renewed, and assist them in understanding its contents. Give patients the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
    Advise patients of the following issues and ask them to alert their prescriber if these occur while taking duloxetine delayed-release capsules.
  • Suicidal Thoughts and Behaviors — Encourage patients, their families, and their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
    Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning, and Warnings and Precautions (5.1)] .
  • Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. All of these might affect the enteric coating.
  • Continuing the Therapy Prescribed — While patients may notice improvement with duloxetine delayed-release capsules therapy in 1 to 4 weeks, advise patients to continue therapy as directed.
  • Hepatotoxicity — Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with duloxetine delayed-release capsules. Instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking duloxetine delayed-release capsules, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of duloxetine delayed-release capsules with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions (5.2)] .
  • Alcohol — Although duloxetine delayed-release capsules do not increase the impairment of mental and motor skills caused by alcohol, use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, duloxetine delayed-release capsules should not be prescribed for patients with substantial alcohol use [see Warnings and Precautions (5.2) and Drug Interactions (7.15)] .
  • Orthostatic Hypotension, Falls and Syncope — Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine delayed-release capsules [see Warnings and Precautions (5.3)] .
  • Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of duloxetine delayed-release capsules and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John’s Wort [see Contraindications (4), Warnings and Precautions (5.4), and Drug Interactions (7.14)] .
    Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Caution patients to seek medical care immediately if they experience these symptoms.
  • Abnormal Bleeding — Caution patients about the concomitant use of duloxetine delayed-release capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.5)] .
  • Severe Skin Reactions — Caution patients that duloxetine delayed-release capsules may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions (5.6)] .
  • Discontinuation of Treatment — Instruct patients that discontinuation of duloxetine delayed-release capsules may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking duloxetine delayed-release capsules without consulting their physician [see Warnings and Precautions (5.7)] .
  • Activation of Mania or Hypomania — Adequately screen patients with depressive symptoms for risk of bipolar disorder (e.g. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with duloxetine delayed-release capsules. Advise patients to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Warnings and Precautions (5.8)] .
  • Angle-Closure Glaucoma — Advise patients that taking duloxetine delayed-release capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. [See Warnings and Precautions (5.9)] .
  • Seizures — Advise patients to inform their physician if they have a history of seizure disorder [see Warnings and Precautions (5.10)] .
  • Effects on Blood Pressure — Caution patients that duloxetine delayed-release capsules may cause an increase in blood pressure [see Warnings and Precautions (5.11)] .
  • Concomitant Medications — Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions [see Dosage and Administration (2.8, 2.9), Contraindications (4), Warnings and Precautions (5.4, 5.12), and Drug Interactions (7)] .
  • Hyponatremia — Advise patients that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including duloxetine delayed-release capsules. Advise patients of the signs and symptoms of hyponatremia [see Warnings and Precautions (5.13)] .
  • Concomitant Illnesses — Advise patients to inform their physicians about all of their medical conditions [see Warnings and Precautions (5.14)] .
  • Duloxetine delayed-release capsules are in a class of medicines that may affect urination. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow [see Warnings and Precautions (5.15)] .
  • Pregnancy and Nursing Mothers.
  • Advise patients to notify their physician if they:
  • Pediatric Use — Safety and efficacy of duloxetine delayed-release capsules in patients 7 to 17 years of age have been established for the treatment of GAD. The types of adverse reactions observed with duloxetine delayed-release capsules in children and adolescents were generally similar to those observed in adults. The safety and effectiveness of duloxetine delayed-release capsules has not been established in pediatric patients less than 18 years of age with other indications. [See Use in Specific Populations (8.4)].
  • Interference with Psychomotor Performance — Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies duloxetine delayed-release capsules have not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that duloxetine delayed-release capsules therapy does not affect their ability to engage in such activities.

Revised:January 2019

Manufactured by: Qingdao BAHEAL Pharmaceutical Co., Ltd.

NO.268 Yingcheng Road, Jimo, Qingdao, PR China

Medication Guide

Duloxetine Delayed-Release Capsules, USP (doo lox’ e teen)

Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?

1. Duloxetine delayed-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).

3. How can I watch for and try to prevent suicidal thoughts and actions?

  • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive, being angry, or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety
  • panic attacks
  • feeling very agitated or restless
  • new or worse irritability
  • trouble sleeping
  • an extreme increase in activity or talking (mania)
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.

What are duloxetine delayed-release capsules?

Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine delayed-release capsules belong to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Duloxetine delayed-release capsules are also used to treat or manage:

  • Generalized Anxiety Disorder (GAD)
  • Diabetic Peripheral Neuropathic Pain (DPNP)
  • Chronic Musculoskeletal Pain

Who should not take duloxetine delayed-release capsules?

Do Not take duloxetine delayed-release capsules if you:

  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
    • Do not take an MAOI within 5 days of stopping duloxetine delayed-release capsules unless directed to do so by your healthcare provider.
    • Do not start duloxetine delayed-release capsules if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

People who take duloxetine delayed-release capsules close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “ What are the possible side effects of duloxetine delayed release capsules?”).

What should I tell my healthcare provider before taking duloxetine delayed-release capsules?

Before starting duloxetine delayed-release capsules, tell your healthcare provider if you:

    • have heart problems or high blood pressure
    • have diabetes (duloxetine delayed-release capsules treatment makes it harder for some people with diabetes to control their blood sugar)
    • have liver problems
    • have kidney problems
    • have glaucoma
    • have or had seizures or convulsions
    • have bipolar disorder or mania
    • have low sodium levels in your blood
    • have delayed stomach emptying
    • have or had bleeding problems
  • are pregnant or plan to become pregnant. It is not known if duloxetine delayed-release capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression or other conditions with duloxetine delayed-release capsules during pregnancy.
  • are breastfeeding or plan to breastfeed. Duloxetine delayed-release capsules can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking duloxetine delayed-release capsules.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Duloxetine delayed-release capsules and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Especially tell your healthcare provider if you take:

  • triptans used to treat migraine headache
  • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs
  • tramadol and fentanyl
  • amphetamines
  • cimetidine
  • the antibiotics ciprofloxacin, enoxacin
  • medicine to treat irregular heart rate (like propafenone, flecainide, quinidine)
  • theophylline
  • the blood thinner warfarin (Coumadin, Jantoven)
  • non-steroidal anti-inflammatory drug (NSAID) (like ibuprofen, naproxen or aspirin)
  • over-the-counter supplements such as tryptophan or St. John’s Wort
  • thioridazine (Mellaril). Mellaril together with duloxetine delayed-release capsules can cause serious heart rhythm problems or sudden death.

Ask your healthcare provider for a list of these medicines if you are not sure.

Do not take duloxetine delayed-release capsules with any other medicine that contain duloxetine.

How should I take duloxetine delayed-release capsules?

  • Take duloxetine delayed-release capsules exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of duloxetine delayed-release capsules until it is the right dose for you.
  • Swallow duloxetine delayed-release capsules whole. Do not chew or crush duloxetine delayed-release capsules.
  • Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well duloxetine delayed-release capsules work.
  • Duloxetine delayed-release capsules may be taken with or without food.
  • If you miss a dose of duloxetine delayed-release capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.
  • If you take too much duloxetine delayed-release capsules, call your healthcare provider or poison control center at 1-800-222-1222 right away, or get emergency treatment.
  • When switching from another antidepressant to duloxetine delayed-release capsules your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

What should I avoid while taking duloxetine delayed-release capsules?

  • Duloxetine delayed-release capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how duloxetine delayed-release capsules affect you.
  • Use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking duloxetine delayed-release capsules.

What are the possible side effects of duloxetine delayed-release capsules?

Duloxetine delayed-release capsules may cause serious side effects, including: See “ What is the most important information I should know about duloxetine delayed-release capsules?

Common possible side effects in people who take duloxetine delayed-release capsules include:

1. liver damage. Symptoms may include:

  • itching
  • right upper abdominal pain
  • dark urine
  • yellow skin or eyes
  • enlarged liver
  • increased liver enzymes

2. changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Duloxetine delayed-release capsules may:

  • increase your blood pressure.
  • decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting duloxetine delayed-release capsules or when increasing the dose.
  • increase risk of falls, especially in elderly.

3. Serotonin Syndrome: This condition can be life-threatening and symptoms may include:

  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures

4. abnormal bleeding: Duloxetine delayed-release capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. severe skin reactions: Duloxetine delayed-release capsules may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

6. discontinuation symptoms: Do not stop duloxetine delayed-release capsules without first talking to your healthcare provider. Stopping duloxetine delayed-release capsules too quickly or changing from another antidepressant too quickly may result in serious symptoms including:

  • anxiety
  • irritability
  • feeling tired or problems sleeping
  • headache
  • sweating
  • dizziness
  • electric shock-like sensations
  • vomiting or nausea
  • diarrhea

7. manic episodes:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

8. visual problems:

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

9. seizures or convulsions

10. low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems

11. problems with urination. Symptoms may include:

  • decreased urine flow
  • unable to pass any urine

The most common side effects of duloxetine delayed-release capsules include:

  • nausea
  • dry mouth
  • sleepiness
  • fatigue
  • constipation
  • loss of appetite
  • increased sweating
  • dizziness

Common possible side effects in children and adolescents who take duloxetine delayed-release capsules include:

  • nausea
  • decreased weight
  • dizziness

Side effects in adults may also occur in children and adolescents who take duloxetine delayed-release capsules. Children and adolescents should have height and weight monitored during treatment.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of duloxetine delayed-release capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.

How should I store duloxetine delayed-release capsules?

Store duloxetine delayed-release capsules at room temperature between 20°C to 25°C (68°F to 77°F ).

Keep duloxetine delayed-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of duloxetine delayed-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about duloxetine delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about duloxetine delayed-release capsules that is written for healthcare professionals.

For more information, call 1-800-545-5979.

What are the ingredients in duloxetine delayed-release capsules?

Active ingredient: duloxetine hydrochloride

Inactive ingredients: hypromellose, hypromellose acetate succinate, sugar spheres (containing corn starch), sucrose, talc, triethyl citrate, gelatin, titanium dioxide, brilliant blue FCF — FD&C Blue 1. The 20mg and 60mg capsules also contain erythrosine -FD&C Red 3.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised: January 2019

Manufactured by: Qingdao BAHEAL Pharmaceutical Co., Ltd.

NO. 268 Yingcheng Road, Jimo, Qingdao, PR China

All Product/Brand names are the trademarks of their respective owner.

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 20 mg, bottle of 60

NDC 70247- 012 -06

Duloxetine

Delayed-Release

Capsules,USP

20 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 60 Capsules

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 20 mg, bottle of 60
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 30

NDC 70247- 013 -03

Duloxetine

Delayed-Release

Capsules,USP

30 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 30 Capsules

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 30
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 90

NDC 70247- 013 -09

Duloxetine

Delayed-Release

Capsules,USP

30 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 90 Capsules

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 90
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 1000

NDC 70247- 013 -10

Duloxetine

Delayed-Release

Capsules,USP

30 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 1000 Capsules

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 30 mg, bottle of 1000
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Realease Capsules 60 mg, bottle of 30

NDC 70247- 014 -03

Duloxetine

Delayed-Release

Capsules,USP

60 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 30 Capsules

PACKAGE LABEL- Duloxetine Delayed-Release Capsules 60 mg, bottle of 30
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Realease Capsules 60 mg, bottle of 60

NDC 70247- 014 -06

Duloxetine

Delayed-Release

Capsules,USP

60 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 60 Capsules

PACKAGE LABEL- Duloxetine Delayed-Realease Capsules 60 mg, bottle of 60
(click image for full-size original)

PACKAGE LABEL- Duloxetine Delayed-Realease Capsules 60 mg, bottle of 500

NDC 70247- 014 -50

Duloxetine

Delayed-Release

Capsules,USP

60 mg

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient.

Rx Only 500 Capsules

PACKAGE LABEL- Duloxetine Delayed-Realease Capsules 60 mg, bottle of 500
(click image for full-size original)
NA duloxetine delayed-release capsules capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70247-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
HYPROMELLOSES
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color green Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 0012;20mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70247-012-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210599 05/05/2018
NA duloxetine delayed-release capsules capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70247-013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSES
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white, blue Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 0013;30mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70247-013-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70247-013-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:70247-013-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210599 05/05/2018
NA duloxetine delayed-release capsules capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70247-014
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 60 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
HYPROMELLOSES
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color green, blue Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 0014;60mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70247-014-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70247-014-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:70247-014-50 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210599 05/05/2018
Labeler — Qingdao BAHEAL Pharmaceutical Co., Ltd. (546626586)
Registrant — Qingdao BAHEAL Pharmaceutical Co., Ltd. (546626586)
Establishment
Name Address ID/FEI Operations
Qingdao BAHEAL Pharmaceutical Co., Ltd. 546626586 manufacture (70247-012), manufacture (70247-013), manufacture (70247-014)
Establishment
Name Address ID/FEI Operations
SCI PHARMTECH, INC. 656069515 api manufacture (70247-012), api manufacture (70247-013), api manufacture (70247-014)

Revised: 01/2021 Qingdao BAHEAL Pharmaceutical Co., Ltd.

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