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Cabergoline
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Cabergoline | .5 mg/1 | 199703 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Ergolines [CS] | CS | 6 members — no class page |
| Ergot Derivative [EPC] | EPC | 6 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076310-001 | CABERGOLINE | TABLET | CABERGOLINE | 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 | 18 | Labeling | Approved | March 18, 2026 | Standard |
| Supplement | 11 | Labeling | Approved | December 13, 2019 | Standard |
| Supplement | 5 | Labeling | Approved | October 26, 2011 | — |
| Supplement | 2 | Labeling | Approved | June 4, 2008 | — |
| Supplement | 1 | Labeling | Approved | January 25, 2007 | — |
| Original application | 1 | Approved | December 29, 2005 | — |
Review documents
- 0 · Original application · January 6, 2006
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Indications and Usage ( 1 ) 4/2025 Warnings and Precautions, Cardiac Valvulopathy and Pericardial Fibrosis ( 5.1 ) 4/2025 Warnings and Precautions, Risks with Use of Cabergoline Tablets for Postpartum Lactation Inhibition or Suppression ( 5.4 ) 4/2025
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. ( 5.4 )
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease. Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered. After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established. HOW SUPPLIED Cabergoline Tablets, USP are a white to off-white, oval shape, flat face, beveled edge tablet containing 0.5 mg Cabergoline USP. Each tablet is debossed "P" bisect line "P" on one side and "673" on the other side. Cabergoline Tablets, USP are available as follows: Bottles of 8 tablets NDC 23155-823-73 STORAGE Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP]. Dispense in original container. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 05/2022 OS673A-01-1-01 logo
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Tablets: 0.5 mg, white to off-white, with functional score, Oval shaped, flat face, beveled edge tablet, scored on one side with the letter "IN" and the letter "G" on either side of the breakline, engraved with the number 118 on the opposite side. Tablets: 0.5 mg white to off-white, with functional score. ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS CABERGOLINE is contraindicated in patients with: • Uncontrolled hypertension. • Known hypersensitivity to ergot derivatives. • History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis, or history of pericardial fibrosis [see Warnings and Precautions (5.1) ] . • History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions (5.2) ] . • Uncontrolled hypertension. ( 4 ) • Known hypersensitivity to ergot derivatives. ( 4 ) • History of cardiac valvular disorders, or pericardial fibrosis. ( 5.1 ) • History of pleural, pulmonary, or retroperitoneal fibrotic disorders. ( 5.2 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Cardiac Valvulopathy and Pericardial Fibrosis : Before initiating cabergoline tablets, perform a cardiovascular evaluation, including echocardiogram, to evaluate for valvular disease. During cabergoline tablets treatment, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated and monitor for chest pain and signs and symptoms of heart failure (if heart failure occurs, exclude valvular fibrosis and pericarditis). Consider additional clinical and diagnostic monitoring at baseline and as necessary during cabergoline tablets treatment. Use cabergoline tablets in patients treated with other drugs associated with valvulopathy only if the potential benefit of cabergoline tablets outweighs the risk. Discontinue cabergoline tablets if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. ( 5.1 ) Pleural, Pulmonary and Retroperitoneal Fibrosis : During cabergoline tablets treatment monitor for signs and symptoms of progressive fibrosis, (e.g., pleuro-pulmonary disease, renal impairment, ureteral/abdominal vascular obstruction). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis at baseline and as necessary during cabergoline tablets treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue cabergoline tablets. ( 5.2 ) Orthostatic Hypotension : Check blood pressure at baseline and during treatment with cabergoline tablets and monitor for orthostatic hypotension. ( 5.3 ) Risks with Use of cabergoline tablets for Postpartum Lactation Inhibition or Suppression : Avoid use of cabergoline tablets for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this unapproved use has been associated with cases of hypertension, stroke, myocardial infarction, seizures, and death. ( 5.4 ) Impulse Control Disorders and Compulsive Behaviors : Specifically ask patients about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with cabergoline tablets. Consider dosage reduction or stopping cabergoline tablets if a patient develops such urges while taking cabergoline tablets. ( 5.5 ) 5.1 Cardiac Valvulopathy and Pericardial Fibrosis Before initiating cabergoline tablets, perform a cardiovascular evaluation, including with an echocardiogram, to evaluate for valvular disease. cabergoline tablets are contraindicated in the presence of valvular disease or pericardial fibrosis [see Contraindications ( 4 )]. Cases of valvular and pericardial fibrosis have often manifested as heart failure. Following cabergoline tablets treatment initiation, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated with new onset edema, cardiac murmur, dyspnea, or heart failure. During cabergoline tablets treatment, monitor for chest pain and signs and symptoms of heart failure and if heart failure occurs, valvular fibrosis and pericarditis should be excluded. Consider clinical and diagnostic monitoring such as erythrocyte sedimentation rate, serum creatinine measurements, chest-x- ray, and other investigations and cardiac imaging at baseline and as necessary while patients are treated with during cabergoline tablets treatment. Use cabergoline tablets in patients treated with other drugs associated with valvulopathy only if the potential benefit of cabergoline tablets outweighs the risk. Discontinue cabergoline tablets if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. Postmarketing cases of cardiac valvulopathy have been reported in patients who received cabergoline tablets. These cases have generally occurred during administration of high doses of cabergoline …
Warnings
openFDA Drug LabelingWARNINGS 1. Pregnancy Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia, eclampsia, and postpartum hypertension, unless the potential benefit is judged to outweigh the possible risk. 2. Fibrotic Complications a. Cardiac Valvulopathy All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with cabergoline. (See CONTRAINDICATIONS ) Postmarketing cases of cardiac valvulopathy have been reported in patients receiving cabergoline. These cases have generally occurred during administration of high doses of cabergoline (> 2mg/day) for the treatment of Parkinson’s disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses of cabergoline for the treatment of hyperprolactinemic disorders. A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n = 27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up. In this study, the use of cabergoline among persons with Parkinson's disease was associated with an increased risk of CVR when compared to non-ergot-derived dopamine agonists (DAs) and levodopa [Incidence Rate (IR) per 10,000 person years of 68.1 (95% confidence interval (CI): 37.2 to 115.3) for cabergoline vs. 10 (95% CI: 5.2 to 19.4) for non-ergot DAs and 11.3 (95% CI: 7.2 to 17) for levodopa]. In the study analysis confined to persons with dopamine agonist-treated hyperprolactinemia (n = 8,386), when compared to non-use (n = 15,147), persons exposed to cabergoline did not have an elevated risk of CVR. The findings with respect to the risk of CVR associated with cabergoline treatment for persons with Parkinson’s disease (increased risk) and those with hyperprolactinemia (no increased risk) are consistent with the findings in other published studies. Physicians should use the lowest effective dose of cabergoline for the treatment of hyperprolactinemic disorders and should periodically reassess the need for continuing therapy with cabergoline. Following treatment initiation, clinical and diagnostic monitoring (for example, chest x-ray, CT scan and cardiac echocardiogram) should be conducted to assess the risk of cardiac valvulopathy. The recommended frequency of routine echocardiographic monitoring is every 6 months to 12 months or as clinically indicated with the presence of signs and symptoms such as edema, new cardiac murmur, dyspnea, or congestive heart failure. Cabergoline should be discontinued if an echocardiogram reveals new valvular regurgitation, valvular restriction or valve leaflet thickening. Cabergoline should be used with caution in patients exposed to other medications associated with valvulopathy. b. Extracardiac Fibrotic Reactions Postmarketing cases of pleural, pericardial, and retroperitoneal fibrosis have been reported following administration of cabergoline. Some reports were in patients previously treated with other ergotinic dopamine agonists. Cabergoline should not be used in patients with a history of cardiac or extracardiac fibrotic disorders. Fibrotic disorders can have an insidious onset and patients should be monitored for manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnea, shortness of breath, persistent cough or chest pain. Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb edema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The safety of cabergoline tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity. In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125 mg, 0.5 mg, 0.75 mg, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table. Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo‐Controlled Trial Adverse Event * Cabergoline (n = 168) 0.125 to 1 mg two times a week Placebo (n = 20) Number (percent) Gastrointestinal Nausea Constipation Abdominal pain Dyspepsia Vomiting 45 (27) 16 (10) 9 (5) 4 (2) 4 (2) 4 (20) 0 1 (5) 0 0 Central and Peripheral Nervous System Headache Dizziness Paresthesia Vertigo 43 (26) 25 (15) 2 (1) 2 (1) 5 (25) 1 (5) 0 0 Body As a Whole Asthenia Fatigue Hot flashes 15 (9) 12 (7) 2 (1) 2 (10) 0 1 (5) Psychiatric Somnolence Depression Nervousness 9 (5) 5 (3) 4 (2) 1 (5) 1 (5) 0 Autonomic Nervous System Postural hypotension 6 (4) 0 Reproductive – Female Breast pain Dysmenorrhea 2 (1) 2 (1) 0 0 Vision Abnormal vision 2 (1) 0 * Reported at ≥ 1% for cabergoline In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3 patients, 2 patients and 2 patients respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10 patients, 3 patients, 3 patients, and 3 patients respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table. Incidence of Reported Adverse Events During the 8-Week, Double-Blind Period of the Comparative Trial with Bromocriptine Adverse Event* Cabergoline(n = 221) Bromocriptine (n = 231) Number (percent) Gastrointestinal Nausea 63 (29) 100 (43) Constipation 15 (7) 21 (9) Abdominal pain 12 (5) 19 (8) Dyspepsia 11 (5) 16 (7) Vomiting 9 (4) 16 (7) Dry mouth 5 (2) 2 (1) Diarrhea 4 (2) 7 (3) Flatulence 4 (2) 3 (1) Throat irritation 2 (1) 0 Toothache 2 (1) 0 Central and Peripheral Nervous System Headache 58 (26) 62 (27) Dizziness 38 (17) 42 (18) Vertigo 9 (4) 10 (4) Paresthesia 5 (2) 6 (3) Body As a Whole Asthenia 13 (6) 15 (6) Fatigue 10 (5) 18 (8) Syncope 3 (1) 3 (1) Influenza-like symptoms 2 (1) 0 Malaise 2 (1) 0 Periorbital edema 2 (1) 2 (1) Peripheral edema 2 (1) 1 Psychiatric Depression 7 (3) 5 (2) Somnolence 5 (2) 5 (2) Anorexia 3 (1) 3 (1) Anxiety 3 (1) 3 (1) Insomnia 3 (1) 2 (1) Impaired concentration 2 (1) 1 Nervousness 2 (1) 5 (2) Cardiovascular Hot flashes Hypotension Dependent edema Palpitation 6 (3) 3 (1) 2 (1) 2 (1) 3 (1) 4 (2) 1 5 (2) Reproductive – Female Breast pain Dysmenorrhea 5 (2) 2 (1) 8 (3) 1 Skin and Appendages Acne Pruritus 3 (1) 2 (1) 0 1 Musculoskeletal Pain Arthralgia 4 (2) 2 (1) 6 (3) 0 Respiratory Rhinitis 2 (1) 9 (4) Vision Abnormal vision 2 (1) 2 (1) * Reported at ≥ 1% for cabergoline Other adverse events that were reported at an incidence of < 1% in the overall clinical studies follow. Body As a Whole: facial edema, influenza-like symptoms, malaise Cardiovascular System: hypotension, syncope, palpitations Digestive System: dry mouth, flatulence, diarrhea, anorexia Metabolic and Nutritional System: weight loss, weight gain Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety Respiratory System: nasal stuff …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Cabergoline tablets, a dopamine receptor agonist, is not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide. Cabergoline tablets, a dopamine receptor agonist, are not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide. ( 7 )
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Pregnancy : If conception occurs during cabergoline tablets therapy, discontinue cabergoline tablets if the risks to the mother or fetus outweigh the benefits to the mother ( 8.1 ) 8.1 Pregnancy Risk Summary If conception occurs during cabergoline tablets therapy, discontinue cabergoline tablets if the risks to the mother or fetus outweigh the benefits to the mother. There are risks to the mother associated with the use of cabergoline tablets ( see Clinical Considerations ). The estimated background risk of major birth defects and miscarriage in patients with hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Maternal Adverse Reactions: In general, avoid use of dopamine agonists, including cabergoline tablets, during pregnancy and the postpartum period. The risks of cabergoline tablets use increase in pregnant females with pregnancy-induced hypertension, preeclampsia, and eclampsia. Data Human Data: Published case reports have not reported a clear association with cabergoline tablets and major birth defects, miscarriage, or adverse fetal outcomes when cabergoline tablets was used during early pregnancy. However, these case reports cannot definitely establish the absence of cabergoline tablets-associated risk. Animal Data: Embryo-fetal development studies have been performed with cabergoline administered by oral gavage in mice, rats, and rabbits: There were no teratogenic effects in the presence of maternal toxicity in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose based on body surface area) during the period of organogenesis. A dose of 0.012 mg/kg/day (approximately 0.14 times the maximum recommended human dose) administered during the period of organogenesis in rats caused an increase in post-implantation loss. This finding is likely due to the role of prolactin in implantation in rats and is not thought to be relevant to humans. At doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) administered during the period of organogenesis in rabbits, cabergoline caused maternal toxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) administered during the period of organogenesis in the rabbit caused an increased occurrence of various malformations. However, in another study in rabbits, no treatment-related malformations or embryofetal toxicity were observed at doses up to 8 mg/kg/day (approximately 300 times the maximum recommended human dose). 8.2 Lactation Risk Summary Cabergoline tablets are not recommended in postpartum women who are breastfeeding or who are planning to breastfeed. Avoid use of cabergoline tablets for the inhibition or suppression of physiologic lactation [see Indications and Usage ( 1 ) and Warnings and Precautions ( 5 . 4 )] . 8.4 Pediatric Use Safety and effectiveness of cabergoline tablets in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of cabergoline tablets did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. 8.6 Hepatic Impairment The use of cabergoline tablets in patients with severe hepatic impairment (HI) (Child-Pugh C) is not recommended. When using cabergoline tablets in patients with moderate HI (Child-Pugh B) increase monitoring of cabergoline tablets-associated adverse reactions. The recommendations for use of cabergoline tablets in patients with mild HI (Child Pugh A) is the same as those with normal hepatic function. Patients w …
Mechanism of Action
openFDA Drug LabelingMechanism of Action: The secretion of prolactin by the anterior pituitary is mainly under hypothalmic inhibitory control, likely exerted through release of dopamine by tuberoinfundibular neurons. Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D 2 receptors. Results of in vitro studies demonstrate that cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that cabergoline has low affinity for dopamine D 1 , α 1 - and α 2 -adrenergic, and 5-HT 1 - and 5-HT 2 -serotonin receptors.
Description
openFDA Drug LabelingDESCRIPTION Cabergoline tablets, USP contain cabergoline, USP a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino) propyl]-3-ethylurea. Its molecular formula is C 26 H 37 N 5 O 2 , and its molecular weight is 451.62 g/mol. The structural formula is as follows: Cabergoline, USP is a white or almost white crystalline powder practically insoluble in water and hexane, very soluble in ethanol, chloroform, acetone, dichloromethane, soluble in 0.1M HCl and freely soluble in toluene. Cabergoline tablets, USP for oral administration, contain 0.5 mg of cabergoline, USP. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. chemical structure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Take measures to support blood pressure, if necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Cabergoline Tablets, USP are white to off-white, oval shaped, flat face, beveled edge tablet with functional score on one side with the letters "IN" and the letter "G" on either side of the breakline, engraved with the number "118" on the opposite side and they are available in the following configuration: 0.5 mg strength, 8-count bottle, and NDC number 50742-118-08. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] . Store the tablets in the original container.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: CABERGOLINE. 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 | January 23, 2013 | Teva Pharmaceuticals USA, Inc. | Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-3157-0 | 50090-3157 | A-S Medication Solutions | 1 BOTTLE in 1 CARTON (50090-3157-0) / 8 TABLET in 1 BOTTLE | October 6, 2017 |
| 50090-5834-0 | 50090-5834 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-5834-0) | October 27, 2021 |
| 50090-6596-0 | 50090-6596 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-6596-0) | August 18, 2023 |
| 50090-7642-0 | 50090-7642 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-7642-0) | August 26, 2025 |
| 69238-2693-1 | 69238-2693 | Amneal Pharmaceuticals NY LLC | 8 TABLET in 1 BOTTLE (69238-2693-1) | October 3, 2024 |
| 27808-315-01 | 27808-315 | Cranbury Pharmaceuticals, LLC | 8 TABLET in 1 BOTTLE (27808-315-01) | August 1, 2026 |
| 23155-823-73 | 23155-823 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8 TABLET in 1 BOTTLE (23155-823-73) | June 15, 2022 |
| 50742-118-08 | 50742-118 | Ingenus Pharmaceuticals, LLC | 8 TABLET in 1 BOTTLE (50742-118-08) | August 9, 2018 |
| 59762-1005-1 | 59762-1005 | Mylan Pharmaceuticals Inc. | 8 TABLET in 1 BOTTLE (59762-1005-1) | September 22, 2014 |
| 70512-860-08 | 70512-860 | SOLA Pharmaceuticals, LLC | 8 TABLET in 1 BOTTLE (70512-860-08) | May 8, 2023 |
| 70069-824-08 | 70069-824 | Somerset Therapeutics, LLC | 8 TABLET in 1 BOTTLE (70069-824-08) | October 18, 2024 |
| 0093-5420-88 | 0093-5420 | Teva Pharmaceuticals USA, Inc. | 1 BOTTLE in 1 CARTON (0093-5420-88) / 8 TABLET in 1 BOTTLE | March 7, 2007 |
| 50090-3157 | 50090-3157 | A-S Medication Solutions | — | March 7, 2007 |
| 50090-5834 | 50090-5834 | A-S Medication Solutions | — | August 9, 2018 |
| 50090-6596 | 50090-6596 | A-S Medication Solutions | — | June 15, 2022 |
| 50090-7642 | 50090-7642 | A-S Medication Solutions | — | October 3, 2024 |
| 69238-2693 | 69238-2693 | Amneal Pharmaceuticals NY LLC | — | October 3, 2024 |
| 27808-315 | 27808-315 | Cranbury Pharmaceuticals, LLC | — | August 1, 2026 |
| 23155-823 | 23155-823 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | June 15, 2022 |
| 50742-118 | 50742-118 | Ingenus Pharmaceuticals, LLC | — | August 9, 2018 |
| 59762-1005 | 59762-1005 | Mylan Pharmaceuticals Inc. | — | September 22, 2014 |
| 70512-860 | 70512-860 | SOLA Pharmaceuticals, LLC | — | May 8, 2023 |
| 70069-824 | 70069-824 | Somerset Therapeutics, LLC | — | October 18, 2024 |
| 0093-5420 | 0093-5420 | Teva Pharmaceuticals USA, Inc. | — | March 7, 2007 |
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 |
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