Medicine
Bromocriptine 5 mg capsule
Bromocriptine 5 mg capsule is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 68°F to 77°F (20°C to 25°C), excursions permitted to 59°F to 86°F…
Key facts
- Active ingredient (INN)
- Bromocriptine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules and 5 more
- Manufacturers
- Zydus LifesciencesIndiaANI PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 68°F to 77°F (20°C to 25°C), excursions permitted to 59°F to 86°F (15°C to 30°C). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G02CB01 Bromocriptine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 January 2009
- Identifiers
- RxCUI 197412, 197411DailyMed set ID 97e7e051-ff64-4381-a869-6c1c364ad822, d69003ee-0b6f-47a9-834e-ba59c02f566c, 72d8eefe-c066-41b6-8922-9586f1cf47a1 +1NDC 65841-654, 68382-110, 0378-7096 +1Application ANDA078899, ANDA077226, NDA017962
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 65841-654-01 | Zydus LifesciencesIndia | 23 January 2009 |
| 30 capsule in 1 bottle | 65841-654-06 | Zydus LifesciencesIndia | 23 January 2009 |
| 100 capsule in 1 bottle | 68382-110-01 | Zydus LifesciencesIndia | 23 January 2009 |
| 30 capsule in 1 bottle | 68382-110-06 | Zydus LifesciencesIndia | 23 January 2009 |
| 30 capsule in 1 bottle | 70954-951-10 | ANI Pharmaceuticals | 6 April 2026 |
| 100 capsule in 1 bottle | 70954-951-20 | ANI Pharmaceuticals | 6 April 2026 |
| 100 capsule in 1 bottle, unit-dose | 0378-7096-01 | Mylan Pharmaceuticals | 1 July 2013 |
| 30 capsule in 1 bottle, unit-dose | 0378-7096-93 | Mylan Pharmaceuticals | 17 June 2013 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 June 1978 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Bromocriptine
Clinical summary
Bromocriptine is an ergot derivative indicated for the treatment of hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults, among other approved uses. It is available as tablets and capsules for oral use. MedsAcross supplies Bromocriptine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BromocriptineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bromocriptine Mesylate prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bromocriptine 5 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.