Hysingla ER (Page 11 of 11)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
Hydrocodone was evaluated for carcinogenic potential in rats and mice. In a two-year bioassay in rats, doses up to 25 mg/kg in males and females were administered orally and no treatment-related neoplasms were observed (exposure is equivalent to 0.2 times the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons). In a two-year bioassay in mice, doses up to 200 mg/kg in males and 100 mg/kg in females were administered orally and no treatment-related neoplasms were observed (exposure is equivalent to 3.5 times and 3.0 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons).

Mutagenesis
Hydrocodone was genotoxic in the mouse lymphoma assay in the presence of rat S9 metabolic activation but not in the absence of rat metabolic activation. However, hydrocodone was not genotoxic in the mouse lymphoma assay with or without human S9 metabolic activation. There was no evidence of genotoxic potential with hydrocodone in an in vitro bacterial reverse mutation assay with Salmonella typhimurium and Escherichia coli with or without metabolic activation or in an in vivo mouse bone marrow micronucleus test with or without metabolic activation.

Impairment of FertilityNo effect on fertility or general reproductive performance was seen with oral administration of hydrocodone to male and female rats at doses up to 25 mg/kg/day (approximately 0.06 times and 0.08 times, respectively, the human hydrocodone dose of 120 mg/day based on AUC exposure comparisons).

14 CLINICAL STUDIES

14.1 Moderate to Severe Chronic Lower Back Pain Study

The efficacy and safety of HYSINGLA ER was evaluated in a randomized double-blind, placebo-controlled, multi-center, 12-week clinical trial in both opioid-experienced and opioid-naïve patients with moderate to severe chronic low back pain.

A total of 905 chronic low back pain patients (opioid naive and opioid-experienced) who were not responsive to their prior analgesic therapy entered an open-label conversion and dose- titration period for up to 45 days with HYSINGLA ER. Patients were dosed once daily with HYSINGLA ER (20 to 120 mg). Patients stopped their prior opioid analgesics and/or nonopioid analgesics prior to starting HYSINGLA ER treatment. Optional use of rescue medication (immediate-release oxycodone 5 mg) up to 2 doses (2 tablets) was permitted during the dose titration period. For inadequately controlled pain, HYSINGLA ER dose was allowed to be increased once every 3–5 days until a stabilized and tolerable dose was identified. During the dose-titration period, 65% of the patients achieved a stable HYSINGLA ER dose and entered the double-blind treatment period. The remaining subjects discontinued from the dose-titration period for the following reasons: adverse events (10%); lack of therapeutic effect (5%); confirmed or suspected diversion (3%); subject’s choice (5%); lost to follow-up (2%); administrative reasons (2%); and failure to achieve protocol-defined reduction in pain score (7%).

Following the dose titration period, 588 patients (65%) were randomized at a ratio of 1:1 into a 12-week double-blind treatment period with their fixed stabilized dose of HYSINGLA ER (or matching placebo). These patients met the study randomization criteria of adequate analgesia (pain reduction of at least 2 points to a score of 4 or less on a 0-10 numerical rating scale) and acceptable tolerability of HYSINGLA ER. Patients randomized to placebo were given a blinded taper of HYSINGLA ER according to a pre-specified tapering schedule, 3 days on each step-down dose (reduced by 25-50% from the previous dose). Patients were allowed to use rescue medication (immediate-release oxycodone 5 mg) up to 6 doses (6 tablets) per day depending on their randomized HYSINGLA ER dose. During the double-blind period, 229 treated patients (77%) completed the 12-week treatment with HYSINGLA ER and 210 patients (72%) completed on placebo. Overall, 10% of patients discontinued due to lack of therapeutic effect (5% in HYSINGLA patients and 15% in placebo patients); 5% of patients discontinued due to adverse events (6% in HYSINGLA ER treated patients and 3% in placebo patients).

HYSINGLA ER provided greater analgesia compared with placebo. There was a statistically significant difference in the weekly average pain scores at Week 12 between the two groups.

The percentage of patients (responders) in each group who demonstrated improvement in their weekly average pain scores at Week 12, as compared with screening is shown in Figure 4. The figure is cumulative, so that patients whose change from screening is, for example, 30%, are also included at every level of improvement below 30%. Patients who did not complete the study were classified as non-responders. Treatment with HYSINGLA ER resulted in a higher proportion of responders, defined as patients with at least a 30% and 50% improvement, as compared with placebo.

Figure 4. Percent Improvement in Pain Intensity

figure-4
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex tablets printed with “HYD 20” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-271-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 30 mg are round, yellow-colored, bi-convex tablets printed with “HYD 30” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-272-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 40 mg are round, grey-colored, bi-convex tablets printed with “HYD 40” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-273-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 60 mg are round, beige-colored, bi-convex tablets printed with “HYD 60” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-274-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 80 mg are round, pink-colored, bi-convex tablets printed with “HYD 80” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-275-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 100 mg are round, blue-colored, bi-convex tablets printed with “HYD 100” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-276-60).

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 120 mg are round, white-colored, bi-convex tablets printed with “HYD 120” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-277-60).

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

Dispense in tight, light-resistant container, as defined by the USP.

Store HYSINGLA ER securely and dispose of properly [see Patient Counseling Information (17)].

17 PATIENT COUNSELING INFORMATION

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

Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store HYSINGLA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions (5.1, 5.3), Drug Abuse and Dependence (9.2)]. Inform patients that leaving HYSINGLA ER unsecured can pose a deadly risk to others in the home.

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused HYSINGLA ER should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse
Inform patients that the use of HYSINGLA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1)]. Instruct patients not to share HYSINGLA ER with others and to take steps to protect HYSINGLA ER from theft or misuse.

Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting HYSINGLA ER or when the dosage is increased, and that it can occur even at recommended dosages

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.3)].

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose


Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with HYSINGLA ER. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see Dosage and Administration (2.2), Warnings and Precautions (5.3)].

Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.

Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered [see Overdosage (10)].

If naloxone is prescribed, also advise patients and caregivers:

  • How to treat with naloxone in the event of an opioid overdose
  • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency
  • To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.

Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3)].

Interaction with Benzodiazepines and other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if HYSINGLA ER is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.6), Drug Interactions (7)].

Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions (7)].

MAOI Interaction
Inform patients to avoid taking HYSINGLA ER while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking HYSINGLA ER [see Drug Interactions (7)].

Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.8)].

Important Administration Instructions
Instruct patients how to properly take HYSINGLA ER, including the following:

  • Use HYSINGLA ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression) [see Warnings and Precautions (5.3)].
  • Swallow tablets whole, one tablet at a time, with enough water to ensure swallowing immediately after placing in the mouth [see Dosage and Administration (2.1)].
  • Do not pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see Dosage and Administration (2.1)].
  • Do not chew, crush, or dissolve the tablets [see Dosage and Administration (2.1)].

Important Discontinuation Instructions

  • In order to avoid developing withdrawal symptoms, instruct patients not to discontinue HYSINGLA ER without first discussing a tapering plan with the prescriber [see Dosage and Administration (2.7)]

Hypotension
Inform patients that HYSINGLA ER may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.9)].

QTc interval prolongation
Inform patients that QT prolongation has been observed with HYSINGLA ER [see Clinical Pharmacology (12.2)]. HYSINGLA ER should be avoided in patients with congenital long QT syndrome. Instruct patients with a history of congestive heart failure or bradyarrhythmias, and patients at risk for electrolyte abnormalities or who are taking other medications known to prolong the QT interval, that periodic monitoring of electrocardiograms and electrolytes may be necessary during therapy with HYSINGLA ER [see Warnings and Precautions (5.10)].

Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in HYSINGLA ER. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindication (4), Adverse Reactions (6)].

Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of HYSINGLA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity
Inform female patients of reproductive potential that HYSINGLA ER can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation
Advise patients that breastfeeding is not recommended during treatment with HYSINGLA ER [see Use in Specific Populations (8.2)]

Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2) Use in Specific Populations (8.3)].

Driving or Operating Heavy Machinery
Inform patients that HYSINGLA ER may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Blood levels of hydrocodone, in some patients, may be high at the end of 24 hours after repeated dose administration. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.16)].

Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention. Instruct patients to monitor their analgesic response following the use of strong laxatives and to contact the prescriber if changes are noted [see Adverse Reactions (6), Clinical Pharmacology (12.2)].

Healthcare professionals can telephone Purdue Pharma’s Medical Services Department (1-888-726-7535) for information on this product.

Purdue Pharma L.P. Stamford, CT 06901-3431

©2021, Purdue Pharma L.P.

U.S. Patent Numbers: 6,733,783; 8,309,060; 8,361,499; 8,529,948; 8,551,520; 8,647,667; 8,808,740; 9,084,816; 9,101,661; 9,095,614; 9,095,615; 9,205,055; 9,393,206; 9,486,412; 9,486,413; 9,492,389; 9,492,390; 9,492,391; 9,545,380; 9,572,779; 9,669,023; 9,669,024; 9,675,610; 9,675,611; 9,682,077: 9,744,136; 9,750,703; 9,763,886; 9,763,933; 9,770,416; 9,770,417; 9,775,809; 9,775,810; 9,861,584; 9,872,837; 10,130,591 and 10,369,109

Medication GuideHYSINGLA® ER (hye-SING-luh) (hydrocodone bitartrate) extended-release tablets, CII
HYSINGLA ER is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.
Important information about HYSINGLA ER:
  • Get emergency help or call 911 right away if you take too much HYSINGLA ER (overdose). When you first start taking HYSINGLA ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking HYSINGLA ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your HYSINGLA ER. They could die from taking it. Selling or giving away HYSINGLA ER is against the law.
  • Store HYSINGLA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take HYSINGLA ER if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
Before taking HYSINGLA ER, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • heart rhythm problems (long QT syndrome)
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of HYSINGLA ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with HYSINGLA ER. It may harm your baby.
  • living in a household where there are small children or someone who has abused street or prescription drugs.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking HYSINGLA ER with certain other medicines can cause serious side effects and could lead to death.
When taking HYSINGLA ER:
  • Do not change your dose. Take HYSINGLA ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
  • Swallow HYSINGLA ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject HYSINGLA ER because this may cause you to overdose and die.
  • HYSINGLA ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.
Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking HYSINGLA ER without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused HYSINGLA ER, by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking HYSINGLA ER, DO NOT:
  • Drive or operate heavy machinery until you know how HYSINGLA ER affects you. HYSINGLA ER can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with HYSINGLA ER may cause you to overdose and die.
The possible side effects of HYSINGLA ER are:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of HYSINGLA ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535

This Medication Guide has been approved by the U.S. Food and Drug Administration.Issued: 03/2021

HYSINGLA ER 20 mg

20 mg
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HYSINGLA ER 30 mg

30 mg
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HYSINGLA ER 40 mg

40 mg
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HYSINGLA ER 60 mg

60 mg
(click image for full-size original)

HYSINGLA ER 80 mg

80 mg
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HYSINGLA ER 100 mg

100 mg
(click image for full-size original)

HYSINGLA ER 120 mg

120 mg
(click image for full-size original)
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-272
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 30 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-272-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-271
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 20 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
ALUMINUM OXIDE
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
COCHINEAL
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-271-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-273
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 40 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-273-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-274
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 60 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE (Beige) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-274-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-275
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 80 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-275-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-276
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
ALUMINUM OXIDE
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-276-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
HYSINGLA ER hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59011-277
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 120 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
MAGNESIUM STEARATE
BUTYLATED HYDROXYTOLUENE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59011-277-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Labeler — Purdue Pharma LP (932323652)
Registrant — Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Operations
Purdue Pharmaceuticals L.P. 132080875 MANUFACTURE (59011-276), MANUFACTURE (59011-273), MANUFACTURE (59011-274), MANUFACTURE (59011-272), MANUFACTURE (59011-275), MANUFACTURE (59011-277), MANUFACTURE (59011-271)

Revised: 03/2021 Purdue Pharma LP

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