Strattera (Page 7 of 7)

14.2 ADHD Studies in Adults

The effectiveness of STRATTERA in the treatment of ADHD was established in 2 randomized, double-blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD.

Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either STRATTERA or placebo. STRATTERA was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of STRATTERA for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on STRATTERA, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

a Atomoxetine base equivalent.

STRATTERA® Capsules 10 mga 18 mga 25 mga 40 mga 60 mga 80 mga 100 mga
Color Opaque White, Opaque White Gold, Opaque White Opaque Blue, Opaque White Opaque Blue, Opaque Blue Opaque Blue, Gold Opaque Brown, Opaque White Opaque Brown, Opaque Brown
Identification LILLY 3227 LILLY 3238 LILLY 3228 LILLY 3229 LILLY 3239 LILLY 3250 LILLY 3251
10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg
NDC Codes:
Bottles of 30 0002-3227-30 0002-3238-30 0002-3228-30 0002-3229-30 0002-3239-30 0002-3250-30 0002-3251-30

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

General Information

Physicians should instruct their patients to read the Medication Guide before starting therapy with STRATTERA and to reread it each time the prescription is renewed.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with STRATTERA and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking STRATTERA.

Suicide Risk

Patients, their families, and their caregivers should be encouraged 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, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dose is adjusted. Families and caregivers of patients should be advised 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.

Severe Liver Injury

Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions (5.2)].

Aggression or Hostility

Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.

Priapism

Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with STRATTERA. The parents or guardians of pediatric patients taking STRATTERA and adult patients taking STRATTERA should be instructed that priapism requires prompt medical attention.

Ocular Irritant

STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Drug-Drug Interaction

Patients should be instructed to consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.

Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations (8.1)].

Food

Patients may take STRATTERA with or without food.

Missed Dose

If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.

Interference with Psychomotor Performance

Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

Copyright © 2002, 2020, Eli Lilly and Company. All rights reserved.

STR-0004-USPI-20200225

MEDICATION GUIDE
STRATTERA® (Stra-TAIR-a)
(atomoxetine) Capsules

Read the Medication Guide that comes with STRATTERA® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child’s treatment with STRATTERA.

What is the most important information I should know about STRATTERA?

The following have been reported with use of STRATTERA:

1. Suicidal thoughts and actions in children and teenagers:

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from STRATTERA clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)
  • had suicide thoughts or actions before starting STRATTERA

The chance for suicidal thoughts and actions may be higher:

  • early during STRATTERA treatment
  • during dose adjustments

Prevent suicidal thoughts and action in your child or teenager by:

  • paying close attention to your child or teenager’s moods, behaviors, thoughts, and feelings during STRATTERA treatment
  • keeping all follow-up visits with your child or teenager’s doctor as scheduled

Watch for the following signs in your child or teenager during STRATTERA treatment:

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

2. Severe liver damage:

STRATTERA can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:

  • itching
  • right upper belly pain
  • dark urine
  • yellow skin or eyes
  • unexplained flu-like symptoms

3. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting STRATTERA.

Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with STRATTERA.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking STRATTERA.

4. New mental (psychiatric) problems in children and teenagers:

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager’s doctor right away about any new mental symptoms because adjusting or stopping STRATTERA treatment may need to be considered.

What Is STRATTERA?

STRATTERA is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). STRATTERA may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

STRATTERA should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

STRATTERA has not been studied in children less than 6 years old.

Who should not take STRATTERA?

STRATTERA should not be taken if you or your child:

  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil® (phenelzine sulfate), Parnate® (tranylcypromine sulfate) and Emsam® (selegiline transdermal system).
  • have an eye problem called narrow angle glaucoma
  • are allergic to anything in STRATTERA. See the end of this Medication Guide for a complete list of ingredients.
  • have or have had a rare tumor called pheochromocytoma.

STRATTERA may not be right for you or your child. Before starting STRATTERA tell your doctor or your child’s doctor about all health conditions (or a family history of) including:

  • have or had suicide thoughts or actions
  • heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
  • mental problems, psychosis, mania, bipolar illness, or depression
  • liver problems
  • are pregnant or plan to become pregnant. It is not known if STRATTERA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
    • There is a pregnancy registry for females who are exposed to ADHD medications, including STRATTERA, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to STRATTERA and their baby. If you or your child becomes pregnant during treatment with STRATTERA, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
  • are breastfeeding or plan to breastfeed. It is not known if STRATTERA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take STRATTERA.

Can STRATTERA be taken with other medicines?

Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. STRATTERA and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether STRATTERA can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • asthma medicines
  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking STRATTERA without talking to your doctor first.

How should STRATTERA be taken?

  • Take STRATTERA exactly as prescribed. STRATTERA comes in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules. Swallow STRATTERA capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow STRATTERA whole. A different medicine may need to be prescribed.
  • Avoid touching a broken STRATTERA capsule. Wash hands and surfaces that touched an open STRATTERA capsule. If any of the powder gets in your eyes or your child’s eyes, rinse them with water right away and call your doctor.
  • STRATTERA can be taken with or without food.
  • STRATTERA is usually taken once or twice a day. Take STRATTERA at the same time each day to help you remember. If you miss a dose of STRATTERA, take it as soon as you remember that day. If you miss a day of STRATTERA, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop STRATTERA treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking STRATTERA. Children should have their height and weight checked often while taking STRATTERA. STRATTERA treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much STRATTERA or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of STRATTERA?

See What is the most important information I should know about STRATTERA? for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.

Other serious side effects include:

  • serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
  • slowing of growth (height and weight) in children
  • problems passing urine including
    • trouble starting or keeping a urine stream
    • cannot fully empty the bladder

Common side effects in children and teenagers include:

  • upset stomach
  • decreased appetite
  • nausea or vomiting
  • dizziness
  • tiredness
  • mood swings

Common side effects in adults include:

  • constipation
  • dry mouth
  • nausea
  • decreased appetite
  • dizziness
  • sexual side effects
  • problems passing urine

Other information for children, teenagers, and adults:

  • Erections that won’t go away (priapism) have occurred rarely during treatment with STRATTERA. If you have an erection that lasts more than 4 hours, seek medical help right away. Because of the potential for lasting damage, including the potential inability to have erections, priapism should be evaluated by a doctor immediately.
  • STRATTERA may affect your ability or your child’s ability to drive or operate heavy machinery. Be careful until you know how STRATTERA affects you or your child.
  • Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store STRATTERA?

  • Store STRATTERA in a safe place at room temperature, 59 to 86°F (15 to 30°C).
  • Keep STRATTERA and all medicines out of the reach of children.

General information about STRATTERA

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

This Medication Guide summarizes the most important information about STRATTERA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about STRATTERA that was written for healthcare professionals. For more information about STRATTERA call 1-800-Lilly-Rx (1-800-545-5979) or visit www.strattera.com.

What are the ingredients in STRATTERA?

Active ingredient: atomoxetine hydrochloride.

Inactive ingredients: pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink.

Nardil® is a registered trademark of Pfizer Inc.

Parnate® is a registered trademark of GlaxoSmithKline.

Emsam® is a registered trademark of Somerset Pharmaceuticals Inc.

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

Revised: 2/2020

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

Copyright © 2003, 2020, Eli Lilly and Company. All rights reserved.

STR-0001-MG-20200225

PACKAGE LABEL — STRATTERA 10 mg bottle of 30

30 Capsules

NDC 0002-3227-30

PU 3227

strattera®

atomoxetine capsules

Rx only

10 mg

Each capsule equivalent to 10 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 10 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 18 mg bottle of 30

30 Capsules

NDC 0002-3238-30

PU 3238

strattera®

atomoxetine capsules

Rx only

18 mg

Each capsule equivalent to 18 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 18 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 25 mg bottle of 30

30 Capsules

NDC 0002-3228-30

PU 3228

strattera®

atomoxetine capsules

Rx only

25 mg

Each capsule equivalent to 25 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA  25 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 40 mg bottle of 30

30 Capsules

NDC 0002-3229-30

PU 3229

strattera®

atomoxetine capsules

Rx only

40 mg

Each capsule equivalent to 40 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 40 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 60 mg bottle of 30

30 Capsules

NDC 0002-3239-30

PU 3239

strattera®

atomoxetine capsules

Rx only

60 mg

Each capsule equivalent to 60 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 60 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 80 mg bottle of 30

30 Capsules

NDC 0002-3250-30

PU 3250

strattera®

atomoxetine capsules

Rx only

80 mg

Each capsule equivalent to 80 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 80 mg bottle of 30
(click image for full-size original)

PACKAGE LABEL — STRATTERA 100 mg bottle of 30

30 Capsules

NDC 0002-3251-30

PU 3251

strattera®

atomoxetine capsules

Rx only

100 mg

Each capsule equivalent to 100 mg atomoxetine

Do not use if Lilly inner seal is missing or broken.

www.strattera.com

Lilly

PACKAGE LABEL -- STRATTERA 100 mg bottle of 30
(click image for full-size original)
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3227
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
titanium dioxide
Product Characteristics
Color white (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3227;10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3227-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 11/26/2002
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3238
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 18 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FERRIC OXIDE YELLOW
titanium dioxide
Product Characteristics
Color white (opaque white) , yellow (gold) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3238;18;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3238-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 11/26/2002
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3228
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
titanium dioxide
Product Characteristics
Color white (opaque white) , blue (opaque blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3228;25;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3228-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 11/26/2002
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
titanium dioxide
Product Characteristics
Color blue (opaque blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3229;40;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3229-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 11/26/2002
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3239
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 60 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
titanium dioxide
Product Characteristics
Color blue (opaque blue) , yellow (gold) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LILLY;3239;60;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3239-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 11/26/2002
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3250
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
titanium dioxide
Product Characteristics
Color white (opaque white) , brown (opaque brown) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LILLY;3250;80;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3250-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 02/14/2005
STRATTERA atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-3251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (Atomoxetine) Atomoxetine 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, Corn
DIMETHICONE
Gelatin, Unspecified
sodium lauryl sulfate
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
titanium dioxide
Product Characteristics
Color brown (opaque brown) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code LILLY;3251;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-3251-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411 02/14/2005
Labeler — Eli Lilly and Company (006421325)

Revised: 02/2020 Eli Lilly and Company

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