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Pramipexole Dihydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Pramipexole Dihydrochloride | .125 mg/1 | 858625 | View |
| Pramipexole Dihydrochloride | .25 mg/1 | 858625 | View |
| Pramipexole Dihydrochloride | .5 mg/1 | 858625 | View |
| Pramipexole Dihydrochloride | .75 mg/1 | 858625 | View |
| Pramipexole Dihydrochloride | 1 mg/1 | 858625 | View |
| Pramipexole Dihydrochloride | 1.5 mg/1 | 858625 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Dopamine Agonists [MoA] | MoA | 9 members — no class page |
| Nonergot Dopamine Agonist [EPC] | EPC | 9 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB | ||
| 202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB | ||
| 202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB | ||
| 202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB | ||
| 202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB | ||
| 202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET | PRAMIPEXOLE DIHYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | March 5, 2024 | Standard |
| Supplement | 13 | Labeling | Approved | March 12, 2021 | Standard |
| Supplement | 11 | Labeling | Approved | March 12, 2021 | Standard |
| Supplement | 9 | Labeling | Approved | March 12, 2021 | Standard |
| Supplement | 8 | Labeling | Approved | March 12, 2021 | Standard |
| Supplement | 7 | Labeling | Approved | April 28, 2016 | Standard |
| Supplement | 5 | Labeling | Approved | September 22, 2015 | Standard |
| Supplement | 1 | Labeling | Approved | September 22, 2015 | Standard |
| Original application | 1 | Approved | October 26, 2012 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260331). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Warnings and Precautions, Withdrawal Symptoms ( 5.11 ) 7/2021
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: • Parkinson’s disease (PD) ( 1.1 ) • Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Parkinson’s Disease-Normal Renal Function* ( 2.2 ) Week Dosage (mg) Total Daily Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.5 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.5 * Doses should not be increased more frequently than every 5 to 7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose. Parkinson’s Disease-Impaired Renal Function (2.2) Creatinine Clearance Starting Dose (mg) Maximum Dose (mg) 50 mL/min 0.125 TID 1.5 TID 30 to 50 mL/min 0.125 BID 0.75 TID 15 to 30 mL/min 0.125 QD 1.5 QD Restless Legs Syndrome* ( 2.3 ) Titration Step Dose (mg) 2 to 3 hours before bedtime 1 0.125 2 (if needed) 0.25 3 (if needed) 0.5 * Dosing interval is 4 to 7 days (14 days in patients with CrCl 20 to 60 mL/min) 2.1 General Dosing Considerations Pramipexole dihydrochloride tablets are taken orally, with or without food. If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted. 2.2 Dosing for Parkinson's Disease In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth. Dosing in Patients with Normal Renal Function Initial Treatment Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1: Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 three times a day 0.375 2 0.25 three times a day 0.75 3 0.5 three times a day 1.5 4 0.75 three times a day 2.25 5 1 three times a day 3 6 1.25 three times a day 3.75 7 1.5 three times a day 4.5 Maintenance Treatment Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day). In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo. When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline. Dosing in Patients with Renal Impairment The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2. Table 2 Dosing of Pramipexole Dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment (creatinine Cl > 50 mL/min) 0.125 three times a day 1.5 three times a day Moderate impairment (creatinine Cl =30 to 50 mL/min) 0.125 twice a day 0.75 three times a day Severe impairment (creatinine Cl =15 to <30 mL/min) 0.125 once a day 1.5 once a day Very severe impairment (creatinine Cl <15 mL/min and hemodialysis patients) The use of pramipexole dihydrochlori …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS 0.125 mg: white to off-white, round, flat, beveled edge uncoated tablets, debossed with ‘SG’ on one side ‘126’ on other side. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. 0.25 mg: white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘27’ on the right side of the bisect. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. 0.5 mg: white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘28’ on the right side of the bisect. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. 0.75 mg: white to off white, oval, flat, beveled edge uncoated tablets, debossed with ‘SG’ on one side ‘129’ on other side. Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. 1.0 mg: white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘30’ on the right side of the bisect. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. 1.5 mg: white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘31’ on the right side of the bisect. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Tablets: 0.125 mg, 0.25 mg (functional scored tablets), 0.5 mg (functional scored tablets), 0.75 mg, 1 mg (functional scored tablets), and 1.5 mg (functional scored tablets) ( 3 ).
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS None. None ( 4 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms (5.1) Symptomatic Orthostatic Hypotension: Monitor during dose escalation (5.2) Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges (5.3) Hallucinations and Psychotic-like Behavior: May occur; risk increases with age (5.4) Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride (5.5) Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride if postural deformity occurs (5.6) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with pramipexole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on pramipexole tablets, some perceived that they had no warning signs (sleep attack) such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment. Somnolence is a common occurrence in patients receiving pramipexole at doses above 1.5 mg/day (0.5 mg three times a day) for Parkinson's disease. In controlled clinical trials in RLS, patients treated with pramipexole dihydrochloride tablets at doses of 0.25 to 0.75 mg once a day, the incidence of somnolence was 6% compared to an incidence of 3% for placebo-treated patients [see Adverse Reactions (6.1) ]. It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with pramipexole dihydrochloride tablets, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with pramipexole dihydrochloride tablets such as the use of concomitant sedating medications or alcohol, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine) [ see Clinical Pharmacology (12.3) ]. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), pramipexole dihydrochloride tablets should ordinarily be discontinued. If a decision is made to continue pramipexole dihydrochloride tablets, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. While dose reduction reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. 5.2 Symptomatic Orthostatic Hypotension Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation. Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to an orthostatic challenge. For these reasons, both Parkinson's disease patients and RLS patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk. In clinical trials of pramipexole, however, and despite clear orthostatic …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1)] • Symptomatic Orthostatic Hypotension [see Warnings and Precautions (5.2)] • Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.3)] • Hallucinations and Psychotic-like Behavior [see Warnings and Precautions (5.4)] • Dyskinesia [see Warnings and Precautions (5.5)] • Postural Deformity [see Warnings and Precautions (5.6)] • Rhabdomyolysis [see Warnings and Precautions (5.8)] • Retinal Pathology [see Warnings and Precautions (5.9)] • Events Reported with Dopaminergic Therapy [see Warnings and Precautions (5.10)] • Withdrawal Symptoms [see Warnings and Precautions (5.11)] Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness,somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency ( 6.1 ) RLS: nausea, somnolence, fatigue, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Parkinson’s Disease During the premarketing development of pramipexole, patients with either early or advanced Parkinson’s disease were enrolled in clinical trials. Apart from the severity and duration of their disease, the two populations differed in their use of concomitant levodopa therapy. Patients with early disease did not receive concomitant levodopa therapy during treatment with pramipexole; those with advanced Parkinson’s disease all received concomitant levodopa treatment. Because these two populations may have differential risks for various adverse reactions, this section will, in general, present adverse-reaction data for these two populations separately. Because the controlled trials performed during premarketing development all used a titration design, with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse reactions. Early Parkinson’s Disease In the three double-blind, placebo-controlled trials of patients with early Parkinson’s disease, the most common adverse reactions (>5%) that were numerically more frequent in the group treated with pramipexole dihydrochloride tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations. Approximately 12% of 388 patients with early Parkinson’s disease and treated with pramipexole dihydrochloride tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse reactions compared with 11% of 235 patients who received placebo. The adverse reactions most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [3.1% on pramipexole dihydrochloride tablets vs 0.4% on placebo]; dizziness [2.1% on pramipexole dihydrochloride tablets vs 1% on placebo]; somnolence [1.6% on pramipexole dihydrochloride tablets vs 0% on placebo]; headache and confusion [1.3% and 1%, respectively, on pramipexole dihydrochloride tablets vs 0% on placebo]) and gastrointestinal system (nausea [2.1% on pramipexole dihydrochloride tablets vs 0.4% on placebo]). Adverse-reaction Incidence in Controlled Clinical Studies in E …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Dopamine antagonists: May diminish the effectiveness of pramipexole ( 7.1 ). 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride tablets.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [ see Data ]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. Because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. The highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (AUC) approximately equal to those in humans receiving the maximum recommended human dose (MRHD) of 4.5 mg/day. There were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma AUC up to approximately 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. The no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. However, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. Pramipexole or metabolites, or both, are present in rat milk [ see Data ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pramipexole dihydrochloride tablets and any potential adverse effects on the breastfed infant from pramipexole dihydrochloride tablets or from the underlying maternal condition. Data In a study of radio-labeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma. 8.4 Pediatric Use Safety and effectiveness of pramipexole dihydrochloride in pediatric patients has not been established. 8.5 Geriatric Use Pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. This resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. In clinical studies with Parkinson's disease patients, 38.7% of patients were older than 65 years. There were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly. In clinical studies with RLS patients, 22% of patients were at least 65 years old. There were no apparent differences …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Pramipexole is a non-ergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D 2 subfamily of dopamine receptors, binding with higher affinity to D 3 than to D 2 or D 4 receptor subtypes. Parkinson’s Disease The precise mechanism of action of pramipexole as a treatment for Parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. The relevance of D 3 receptor binding in Parkinson’s disease is unknown. Restless Legs Syndrome (RLS) The precise mechanism of action of pramipexole dihydrochloride tablets as a treatment for RLS is unknown. Although the pathophysiology of RLS is largely unknown, neuropharmacological evidence suggests primary dopaminergic system involvement. Positron Emission Tomographic (PET) studies suggest that a mild striatal presynaptic dopaminergic dysfunction may be involved in the pathogenesis of RLS.
Description
openFDA Drug Labeling11 DESCRIPTION Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S 2HCl H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg : Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg: Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg: Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg: Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate, USP form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis). Structural Formula
Overdosage
openFDA Drug Labeling10 OVERDOSAGE There is no clinical experience with significant overdosage. One patient took 11 mg/day of pramipexole for 2 days in a clinical trial for an investigational use. Blood pressure remained stable although pulse rate increased to between 100 and 120 beats/minute. No other adverse reactions were reported related to the increased dose. There is no known antidote for overdosage of a dopamine agonist. If signs of central nervous system stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdosage has not been assessed. Management of overdose may require general supportive measures along with gastric lavage, intravenous fluids, and electrocardiogram monitoring.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Pramipexole Dihydrochloride Tablets are available as follows: Pramipexole Dihydrochloride Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42 Pramipexole Dihydrochloride Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41 Pramipexole Dihydrochloride Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40 Pramipexole Dihydrochloride Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31 Pramipexole Dihydrochloride Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31 Pramipexole Dihydrochloride Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
16.1 How Supplied Pramipexole Dihydrochloride Tablets are available as follows: Pramipexole Dihydrochloride Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42 Pramipexole Dihydrochloride Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41 Pramipexole Dihydrochloride Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40 Pramipexole Dihydrochloride Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31 Pramipexole Dihydrochloride Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31 Pramipexole Dihydrochloride Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: PRAMIPEXOLE DIHYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class III | September 18, 2019 | Macleods Pharma Usa Inc | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg | Terminated |
| Class II | February 17, 2016 | Macleods Pharma Usa Inc | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2455-0 | 50090-2455 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-2455-0) | August 12, 2016 |
| 50090-3280-0 | 50090-3280 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3280-0) | November 27, 2017 |
| 50090-5036-0 | 50090-5036 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5036-0) | May 6, 2020 |
| 50090-7816-0 | 50090-7816 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7816-0) | December 10, 2025 |
| 62332-003-90 | 62332-003 | Alembic Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (62332-003-90) | March 22, 2016 |
| 62332-004-90 | 62332-004 | Alembic Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (62332-004-90) | March 22, 2016 |
| 62332-005-90 | 62332-005 | Alembic Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (62332-005-90) | March 22, 2016 |
| 62332-006-90 | 62332-006 | Alembic Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (62332-006-90) | March 22, 2016 |
| 62332-007-90 | 62332-007 | Alembic Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (62332-007-90) | March 22, 2016 |
| 46708-003-90 | 46708-003 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-003-90) | March 22, 2016 |
| 46708-004-90 | 46708-004 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-004-90) | March 22, 2016 |
| 46708-005-90 | 46708-005 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-005-90) | March 22, 2016 |
| 46708-006-90 | 46708-006 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-006-90) | March 22, 2016 |
| 46708-007-90 | 46708-007 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-007-90) | March 22, 2016 |
| 46708-611-90 | 46708-611 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-611-90) | March 22, 2016 |
| 46708-612-90 | 46708-612 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-612-90) | March 22, 2016 |
| 46708-613-90 | 46708-613 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-613-90) | March 22, 2016 |
| 46708-614-90 | 46708-614 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-614-90) | March 22, 2016 |
| 46708-615-90 | 46708-615 | Alembic Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (46708-615-90) | March 22, 2016 |
| 60687-570-01 | 60687-570 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-570-01) / 1 TABLET in 1 BLISTER PACK (60687-570-11) | August 18, 2020 |
| 60687-581-21 | 60687-581 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-581-21) / 1 TABLET in 1 BLISTER PACK (60687-581-11) | August 13, 2020 |
| 60687-592-21 | 60687-592 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-592-21) / 1 TABLET in 1 BLISTER PACK (60687-592-11) | August 10, 2020 |
| 65862-604-78 | 65862-604 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-604-78) / 10 TABLET in 1 BLISTER PACK (65862-604-10) | October 26, 2012 |
| 65862-604-81 | 65862-604 | Aurobindo Pharma Limited | 8000 TABLET in 1 BAG (65862-604-81) | October 26, 2012 |
| 65862-604-90 | 65862-604 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-604-90) | October 26, 2012 |
| 65862-604-99 | 65862-604 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-604-99) | October 26, 2012 |
| 65862-605-78 | 65862-605 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-605-78) / 10 TABLET in 1 BLISTER PACK (65862-605-10) | October 26, 2012 |
| 65862-605-81 | 65862-605 | Aurobindo Pharma Limited | 8000 TABLET in 1 BAG (65862-605-81) | October 26, 2012 |
| 65862-605-90 | 65862-605 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-605-90) | October 26, 2012 |
| 65862-605-99 | 65862-605 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-605-99) | October 26, 2012 |
| 65862-606-59 | 65862-606 | Aurobindo Pharma Limited | 5000 TABLET in 1 BAG (65862-606-59) | October 26, 2012 |
| 65862-606-78 | 65862-606 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-606-78) / 10 TABLET in 1 BLISTER PACK (65862-606-10) | October 26, 2012 |
| 65862-606-90 | 65862-606 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-606-90) | October 26, 2012 |
| 65862-606-99 | 65862-606 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-606-99) | October 26, 2012 |
| 65862-607-35 | 65862-607 | Aurobindo Pharma Limited | 3500 TABLET in 1 BAG (65862-607-35) | October 26, 2012 |
| 65862-607-78 | 65862-607 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-607-78) / 10 TABLET in 1 BLISTER PACK (65862-607-10) | October 26, 2012 |
| 65862-607-90 | 65862-607 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-607-90) | October 26, 2012 |
| 65862-607-99 | 65862-607 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-607-99) | October 26, 2012 |
| 65862-608-35 | 65862-608 | Aurobindo Pharma Limited | 3500 TABLET in 1 BAG (65862-608-35) | October 26, 2012 |
| 65862-608-78 | 65862-608 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-608-78) / 10 TABLET in 1 BLISTER PACK (65862-608-10) | October 26, 2012 |
| 65862-608-90 | 65862-608 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-608-90) | October 26, 2012 |
| 65862-608-99 | 65862-608 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-608-99) | October 26, 2012 |
| 65862-609-26 | 65862-609 | Aurobindo Pharma Limited | 2500 TABLET in 1 BAG (65862-609-26) | October 26, 2012 |
| 65862-609-78 | 65862-609 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (65862-609-78) / 10 TABLET in 1 BLISTER PACK (65862-609-10) | October 26, 2012 |
| 65862-609-90 | 65862-609 | Aurobindo Pharma Limited | 90 TABLET in 1 BOTTLE (65862-609-90) | October 26, 2012 |
| 65862-609-99 | 65862-609 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-609-99) | October 26, 2012 |
| 63629-5013-1 | 63629-5013 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-5013-1) | May 22, 2013 |
| 63629-5013-2 | 63629-5013 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-5013-2) | July 16, 2013 |
| 63629-5013-3 | 63629-5013 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-5013-3) | September 5, 2024 |
| 63629-5042-1 | 63629-5042 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-5042-1) | July 16, 2013 |
| 63629-5042-2 | 63629-5042 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-5042-2) | September 10, 2013 |
| 63629-8289-1 | 63629-8289 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-8289-1) | January 10, 2020 |
| 71335-0584-1 | 71335-0584 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0584-1) | July 2, 2018 |
| 71335-0584-2 | 71335-0584 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0584-2) | April 24, 2018 |
| 71335-0584-3 | 71335-0584 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0584-3) | May 2, 2022 |
| 71335-1504-1 | 71335-1504 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1504-1) | December 28, 2021 |
| 71335-1504-2 | 71335-1504 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1504-2) | February 11, 2020 |
| 71335-1537-1 | 71335-1537 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1537-1) | March 16, 2020 |
| 71335-1537-2 | 71335-1537 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1537-2) | November 23, 2021 |
| 71335-1808-1 | 71335-1808 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1808-1) | December 29, 2021 |
| 71335-1808-2 | 71335-1808 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1808-2) | April 19, 2021 |
| 71335-1808-3 | 71335-1808 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1808-3) | December 29, 2021 |
| 71335-1877-1 | 71335-1877 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1877-1) | May 28, 2021 |
| 71335-1877-2 | 71335-1877 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1877-2) | December 29, 2021 |
| 71335-1877-3 | 71335-1877 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1877-3) | December 29, 2021 |
| 71335-2167-1 | 71335-2167 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2167-1) | September 1, 2022 |
| 72162-2569-9 | 72162-2569 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2569-9) | November 17, 2025 |
| 68462-330-05 | 68462-330 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-330-05) | October 8, 2010 |
| 68462-330-11 | 68462-330 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-330-11) / 10 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 68462-330-63 | 68462-330 | Glenmark Pharmaceuticals Inc., USA | 63 TABLET in 1 BOTTLE (68462-330-63) | October 8, 2010 |
| 68462-330-90 | 68462-330 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-330-90) | October 8, 2010 |
| 68462-331-05 | 68462-331 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-331-05) | October 8, 2010 |
| 68462-331-11 | 68462-331 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-331-11) / 10 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 68462-331-90 | 68462-331 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-331-90) | October 8, 2010 |
| 68462-332-05 | 68462-332 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-332-05) | October 8, 2010 |
| 68462-332-11 | 68462-332 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-332-11) / 10 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 68462-332-90 | 68462-332 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-332-90) | October 8, 2010 |
| 68462-333-05 | 68462-333 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-333-05) | October 8, 2010 |
| 68462-333-11 | 68462-333 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-333-11) / 10 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 68462-333-90 | 68462-333 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-333-90) | October 8, 2010 |
| 68462-334-05 | 68462-334 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-334-05) | October 8, 2010 |
| 68462-334-11 | 68462-334 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-334-11) / 10 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 68462-334-90 | 68462-334 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-334-90) | October 8, 2010 |
| 68462-627-05 | 68462-627 | Glenmark Pharmaceuticals Inc., USA | 500 TABLET in 1 BOTTLE (68462-627-05) | January 31, 2016 |
| 68462-627-90 | 68462-627 | Glenmark Pharmaceuticals Inc., USA | 90 TABLET in 1 BOTTLE (68462-627-90) | January 31, 2016 |
| 60429-085-90 | 60429-085 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-085-90) | April 7, 2025 |
| 60429-086-90 | 60429-086 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-086-90) | April 7, 2025 |
| 60429-087-90 | 60429-087 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-087-90) | April 7, 2025 |
| 60429-088-90 | 60429-088 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-088-90) | May 2, 2025 |
| 60429-089-90 | 60429-089 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-089-90) | April 7, 2025 |
| 60429-090-90 | 60429-090 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-090-90) | April 7, 2025 |
| 33342-031-06 | 33342-031 | Macleods Pharmaceuticals Limited | 30 BLISTER PACK in 1 CARTON (33342-031-06) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-031-10 | 33342-031 | Macleods Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (33342-031-10) | September 21, 2012 |
| 33342-031-12 | 33342-031 | Macleods Pharmaceuticals Limited | 100 BLISTER PACK in 1 CARTON (33342-031-12) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-031-15 | 33342-031 | Macleods Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (33342-031-15) | September 21, 2012 |
| 33342-032-06 | 33342-032 | Macleods Pharmaceuticals Limited | 30 BLISTER PACK in 1 CARTON (33342-032-06) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-032-10 | 33342-032 | Macleods Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (33342-032-10) | September 21, 2012 |
| 33342-032-12 | 33342-032 | Macleods Pharmaceuticals Limited | 100 BLISTER PACK in 1 CARTON (33342-032-12) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-032-15 | 33342-032 | Macleods Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (33342-032-15) | September 21, 2012 |
| 33342-033-06 | 33342-033 | Macleods Pharmaceuticals Limited | 30 BLISTER PACK in 1 CARTON (33342-033-06) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-033-10 | 33342-033 | Macleods Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (33342-033-10) | September 21, 2012 |
| 33342-033-12 | 33342-033 | Macleods Pharmaceuticals Limited | 100 BLISTER PACK in 1 CARTON (33342-033-12) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-033-15 | 33342-033 | Macleods Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (33342-033-15) | September 21, 2012 |
| 33342-034-06 | 33342-034 | Macleods Pharmaceuticals Limited | 30 BLISTER PACK in 1 CARTON (33342-034-06) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-034-10 | 33342-034 | Macleods Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (33342-034-10) | September 21, 2012 |
| 33342-034-12 | 33342-034 | Macleods Pharmaceuticals Limited | 100 BLISTER PACK in 1 CARTON (33342-034-12) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-034-15 | 33342-034 | Macleods Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (33342-034-15) | September 21, 2012 |
| 33342-035-06 | 33342-035 | Macleods Pharmaceuticals Limited | 30 BLISTER PACK in 1 CARTON (33342-035-06) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-035-10 | 33342-035 | Macleods Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (33342-035-10) | September 21, 2012 |
| 33342-035-12 | 33342-035 | Macleods Pharmaceuticals Limited | 100 BLISTER PACK in 1 CARTON (33342-035-12) / 1 TABLET in 1 BLISTER PACK | September 21, 2012 |
| 33342-035-15 | 33342-035 | Macleods Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (33342-035-15) | September 21, 2012 |
| 0904-6704-61 | 0904-6704 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-6704-61) / 1 TABLET in 1 BLISTER PACK | October 8, 2010 |
| 0615-8551-39 | 0615-8551 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8551-39) | October 7, 2024 |
| 0615-8552-39 | 0615-8552 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8552-39) | October 8, 2024 |
| 57237-180-90 | 57237-180 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-180-90) | October 26, 2012 |
| 57237-180-99 | 57237-180 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-180-99) | October 26, 2012 |
| 57237-181-90 | 57237-181 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-181-90) | October 26, 2012 |
| 57237-181-99 | 57237-181 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-181-99) | October 26, 2012 |
| 57237-182-90 | 57237-182 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-182-90) | October 26, 2012 |
| 57237-182-99 | 57237-182 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-182-99) | October 26, 2012 |
| 57237-183-90 | 57237-183 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-183-90) | October 26, 2012 |
| 57237-183-99 | 57237-183 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-183-99) | October 26, 2012 |
| 57237-184-90 | 57237-184 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-184-90) | October 26, 2012 |
| 57237-184-99 | 57237-184 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-184-99) | October 26, 2012 |
| 57237-185-90 | 57237-185 | Rising Pharma Holdings, Inc. | 90 TABLET in 1 BOTTLE (57237-185-90) | October 26, 2012 |
| 57237-185-99 | 57237-185 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (57237-185-99) | October 26, 2012 |
| 50228-126-10 | 50228-126 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-126-10) | October 29, 2014 |
| 50228-126-90 | 50228-126 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-126-90) | October 29, 2014 |
| 50228-127-10 | 50228-127 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-127-10) | October 29, 2014 |
| 50228-127-90 | 50228-127 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-127-90) | October 29, 2014 |
| 50228-128-10 | 50228-128 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-128-10) | October 29, 2014 |
| 50228-128-90 | 50228-128 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-128-90) | October 29, 2014 |
| 50228-129-10 | 50228-129 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-129-10) | October 29, 2014 |
| 50228-129-90 | 50228-129 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-129-90) | October 29, 2014 |
| 50228-130-10 | 50228-130 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-130-10) | October 29, 2014 |
| 50228-130-90 | 50228-130 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-130-90) | October 29, 2014 |
| 50228-131-10 | 50228-131 | ScieGen Pharmaceuticals Inc | 1000 TABLET in 1 BOTTLE (50228-131-10) | October 29, 2014 |
| 50228-131-90 | 50228-131 | ScieGen Pharmaceuticals Inc | 90 TABLET in 1 BOTTLE (50228-131-90) | October 29, 2014 |
| 64380-746-05 | 64380-746 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-746-05) | February 15, 2021 |
| 64380-747-01 | 64380-747 | Strides Pharma Science Limited | 10 BLISTER PACK in 1 CARTON (64380-747-01) / 10 TABLET in 1 BLISTER PACK | February 15, 2021 |
| 64380-747-05 | 64380-747 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-747-05) | February 15, 2021 |
| 64380-748-01 | 64380-748 | Strides Pharma Science Limited | 10 BLISTER PACK in 1 CARTON (64380-748-01) / 10 TABLET in 1 BLISTER PACK | February 15, 2021 |
| 64380-748-05 | 64380-748 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-748-05) | February 15, 2021 |
| 64380-749-05 | 64380-749 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-749-05) | February 15, 2021 |
| 64380-750-01 | 64380-750 | Strides Pharma Science Limited | 10 BLISTER PACK in 1 CARTON (64380-750-01) / 10 TABLET in 1 BLISTER PACK | February 15, 2021 |
| 64380-750-05 | 64380-750 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-750-05) | February 15, 2021 |
| 64380-751-01 | 64380-751 | Strides Pharma Science Limited | 10 BLISTER PACK in 1 CARTON (64380-751-01) / 10 TABLET in 1 BLISTER PACK | February 15, 2021 |
| 64380-751-05 | 64380-751 | Strides Pharma Science Limited | 90 TABLET in 1 BOTTLE (64380-751-05) | February 15, 2021 |
| 13668-091-05 | 13668-091 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-091-05) | October 8, 2010 |
| 13668-091-30 | 13668-091 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-091-30) | October 8, 2010 |
| 13668-091-42 | 13668-091 | Torrent Pharmaceuticals Limited | 6000 TABLET in 1 BOTTLE (13668-091-42) | October 8, 2010 |
| 13668-091-90 | 13668-091 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-091-90) | October 8, 2010 |
| 13668-092-05 | 13668-092 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-092-05) | October 8, 2010 |
| 13668-092-30 | 13668-092 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-092-30) | October 8, 2010 |
| 13668-092-41 | 13668-092 | Torrent Pharmaceuticals Limited | 5500 TABLET in 1 BOTTLE (13668-092-41) | October 8, 2010 |
| 13668-092-90 | 13668-092 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-092-90) | October 8, 2010 |
| 13668-093-05 | 13668-093 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-093-05) | October 8, 2010 |
| 13668-093-30 | 13668-093 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-093-30) | October 8, 2010 |
| 13668-093-40 | 13668-093 | Torrent Pharmaceuticals Limited | 4000 TABLET in 1 BOTTLE (13668-093-40) | October 8, 2010 |
| 13668-093-90 | 13668-093 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-093-90) | October 8, 2010 |
| 13668-094-05 | 13668-094 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-094-05) | October 8, 2010 |
| 13668-094-30 | 13668-094 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-094-30) | October 8, 2010 |
| 13668-094-31 | 13668-094 | Torrent Pharmaceuticals Limited | 2500 TABLET in 1 BOTTLE (13668-094-31) | October 8, 2010 |
| 13668-094-90 | 13668-094 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-094-90) | October 8, 2010 |
| 13668-095-05 | 13668-095 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-095-05) | October 8, 2010 |
| 13668-095-15 | 13668-095 | Torrent Pharmaceuticals Limited | 1500 TABLET in 1 BOTTLE (13668-095-15) | October 8, 2010 |
| 13668-095-30 | 13668-095 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-095-30) | October 8, 2010 |
| 13668-095-90 | 13668-095 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-095-90) | October 8, 2010 |
| 13668-184-05 | 13668-184 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-184-05) | October 8, 2010 |
| 13668-184-30 | 13668-184 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-184-30) | October 8, 2010 |
| 13668-184-31 | 13668-184 | Torrent Pharmaceuticals Limited | 2500 TABLET in 1 BOTTLE (13668-184-31) | October 8, 2010 |
| 13668-184-90 | 13668-184 | Torrent Pharmaceuticals Limited | 90 TABLET in 1 BOTTLE (13668-184-90) | October 8, 2010 |
| 29300-207-10 | 29300-207 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-207-10) | March 1, 2019 |
| 29300-207-16 | 29300-207 | Unichem Pharmaceuticals (USA), Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (29300-207-16) | March 1, 2019 |
| 29300-207-19 | 29300-207 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-207-19) | March 1, 2019 |
| 29300-208-10 | 29300-208 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-208-10) | March 1, 2019 |
| 29300-208-19 | 29300-208 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-208-19) | March 1, 2019 |
| 29300-209-10 | 29300-209 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-209-10) | March 1, 2019 |
| 29300-209-19 | 29300-209 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-209-19) | March 1, 2019 |
| 29300-210-10 | 29300-210 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-210-10) | March 1, 2019 |
| 29300-210-19 | 29300-210 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-210-19) | March 1, 2019 |
| 29300-211-10 | 29300-211 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-211-10) | March 1, 2019 |
| 29300-211-19 | 29300-211 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-211-19) | March 1, 2019 |
| 29300-270-10 | 29300-270 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-270-10) | March 1, 2019 |
| 29300-270-19 | 29300-270 | Unichem Pharmaceuticals (USA), Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (29300-270-19) | March 1, 2019 |
| 50090-2455 | 50090-2455 | A-S Medication Solutions | — | October 26, 2012 |
| 50090-3280 | 50090-3280 | A-S Medication Solutions | — | October 26, 2012 |
| 50090-5036 | 50090-5036 | A-S Medication Solutions | — | October 26, 2012 |
| 50090-7816 | 50090-7816 | A-S Medication Solutions | — | October 8, 2010 |
| 62332-003 | 62332-003 | Alembic Pharmaceuticals Inc. | — | March 22, 2016 |
| 62332-004 | 62332-004 | Alembic Pharmaceuticals Inc. | — | March 22, 2016 |
| 62332-005 | 62332-005 | Alembic Pharmaceuticals Inc. | — | March 22, 2016 |
| 62332-006 | 62332-006 | Alembic Pharmaceuticals Inc. | — | March 22, 2016 |
| 62332-007 | 62332-007 | Alembic Pharmaceuticals Inc. | — | March 22, 2016 |
| 46708-003 | 46708-003 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-004 | 46708-004 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-005 | 46708-005 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-006 | 46708-006 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-007 | 46708-007 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-611 | 46708-611 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-612 | 46708-612 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-613 | 46708-613 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-614 | 46708-614 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 46708-615 | 46708-615 | Alembic Pharmaceuticals Limited | — | March 22, 2016 |
| 60687-570 | 60687-570 | American Health Packaging | — | August 18, 2020 |
| 60687-581 | 60687-581 | American Health Packaging | — | August 13, 2020 |
| 60687-592 | 60687-592 | American Health Packaging | — | August 10, 2020 |
| 65862-604 | 65862-604 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 65862-605 | 65862-605 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 65862-606 | 65862-606 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 65862-607 | 65862-607 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 65862-608 | 65862-608 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 65862-609 | 65862-609 | Aurobindo Pharma Limited | — | October 26, 2012 |
| 63629-5013 | 63629-5013 | Bryant Ranch Prepack | — | October 8, 2010 |
| 63629-5042 | 63629-5042 | Bryant Ranch Prepack | — | October 8, 2010 |
| 63629-8289 | 63629-8289 | Bryant Ranch Prepack | — | October 26, 2012 |
| 71335-0584 | 71335-0584 | Bryant Ranch Prepack | — | October 8, 2010 |
| 71335-1504 | 71335-1504 | Bryant Ranch Prepack | — | October 26, 2012 |
| 71335-1537 | 71335-1537 | Bryant Ranch Prepack | — | October 26, 2012 |
| 71335-1808 | 71335-1808 | Bryant Ranch Prepack | — | October 26, 2012 |
| 71335-1877 | 71335-1877 | Bryant Ranch Prepack | — | October 26, 2012 |
| 71335-2167 | 71335-2167 | Bryant Ranch Prepack | — | October 8, 2010 |
| 72162-2569 | 72162-2569 | Bryant Ranch Prepack | — | October 8, 2010 |
| 68462-330 | 68462-330 | Glenmark Pharmaceuticals Inc., USA | — | October 8, 2010 |
| 68462-331 | 68462-331 | Glenmark Pharmaceuticals Inc., USA | — | October 8, 2010 |
| 68462-332 | 68462-332 | Glenmark Pharmaceuticals Inc., USA | — | October 8, 2010 |
| 68462-333 | 68462-333 | Glenmark Pharmaceuticals Inc., USA | — | October 8, 2010 |
| 68462-334 | 68462-334 | Glenmark Pharmaceuticals Inc., USA | — | October 8, 2010 |
| 68462-627 | 68462-627 | Glenmark Pharmaceuticals Inc., USA | — | January 31, 2016 |
| 60429-085 | 60429-085 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 60429-086 | 60429-086 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 60429-087 | 60429-087 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 60429-088 | 60429-088 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 60429-089 | 60429-089 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 60429-090 | 60429-090 | Golden State Medical Supply, Inc. | — | October 28, 2014 |
| 33342-031 | 33342-031 | Macleods Pharmaceuticals Limited | — | September 21, 2012 |
| 33342-032 | 33342-032 | Macleods Pharmaceuticals Limited | — | September 21, 2012 |
| 33342-033 | 33342-033 | Macleods Pharmaceuticals Limited | — | September 21, 2012 |
| 33342-034 | 33342-034 | Macleods Pharmaceuticals Limited | — | September 21, 2012 |
| 33342-035 | 33342-035 | Macleods Pharmaceuticals Limited | — | September 21, 2012 |
| 0904-6704 | 0904-6704 | Major Pharmaceuticals | — | October 8, 2010 |
| 0615-8551 | 0615-8551 | NCS HealthCare of KY, LLC dba Vangard Labs | — | October 8, 2010 |
| 0615-8552 | 0615-8552 | NCS HealthCare of KY, LLC dba Vangard Labs | — | October 8, 2010 |
| 57237-180 | 57237-180 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 57237-181 | 57237-181 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 57237-182 | 57237-182 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 57237-183 | 57237-183 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 57237-184 | 57237-184 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 57237-185 | 57237-185 | Rising Pharma Holdings, Inc. | — | October 26, 2012 |
| 50228-126 | 50228-126 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 50228-127 | 50228-127 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 50228-128 | 50228-128 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 50228-129 | 50228-129 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 50228-130 | 50228-130 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 50228-131 | 50228-131 | ScieGen Pharmaceuticals Inc | — | October 29, 2014 |
| 64380-746 | 64380-746 | Strides Pharma Science Limited | — | February 15, 2021 |
| 64380-747 | 64380-747 | Strides Pharma Science Limited | — | February 15, 2021 |
| 64380-748 | 64380-748 | Strides Pharma Science Limited | — | February 15, 2021 |
| 64380-749 | 64380-749 | Strides Pharma Science Limited | — | February 15, 2021 |
| 64380-750 | 64380-750 | Strides Pharma Science Limited | — | February 15, 2021 |
| 64380-751 | 64380-751 | Strides Pharma Science Limited | — | February 15, 2021 |
| 13668-091 | 13668-091 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 13668-092 | 13668-092 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 13668-093 | 13668-093 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 13668-094 | 13668-094 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 13668-095 | 13668-095 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 13668-184 | 13668-184 | Torrent Pharmaceuticals Limited | — | October 8, 2010 |
| 29300-207 | 29300-207 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
| 29300-208 | 29300-208 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
| 29300-209 | 29300-209 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
| 29300-210 | 29300-210 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
| 29300-211 | 29300-211 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
| 29300-270 | 29300-270 | Unichem Pharmaceuticals (USA), Inc. | — | March 1, 2019 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.