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MedsAcross

Medicine

Bromocriptine 2.5 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Bromocriptine 2.5 mg tablet is a generic prescription medicine for oral use, made by 5 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F) Dispense in a tight, light-resistant…

Key facts

Active ingredient (INN)
Bromocriptine
Brand
Sold under the generic name
Strength
2.5 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 100 tablets, 30 blister pack and 5 more
Manufacturers
ANI PharmaceuticalsPadagisSandozAmerican Health PackagingRemedyrepack
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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
13 January 1998
Identifiers
RxCUI 197411, 197412DailyMed set ID 0ee2da00-faf8-4c51-a696-9462fa4f6050, c43c300d-8aec-4020-984a-42c1a917c08f, 17f3a343-1782-4799-95ba-31dfe93be2cf +2NDC 0574-0106, 0781-5325, 70954-978 +2Application ANDA077646, ANDA074631, 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.

PackCodeLabelerMarketed since
30 tablet in 1 bottle70954-978-10ANI Pharmaceuticals15 June 2025
100 tablet in 1 bottle70954-978-20ANI Pharmaceuticals15 June 2025
100 tablet in 1 bottle, plastic0574-0106-01Padagis1 April 2014
30 tablet in 1 bottle, plastic0574-0106-03Padagis1 April 2014
100 tablet in 1 bottle0781-5325-01Sandoz13 January 1998
30 tablet in 1 bottle0781-5325-31Sandoz13 January 1998
30 blister pack in 1 carton / 1 tablet in 1 blister pack60687-931-21American Health Packaging12 June 2026
50 pouch in 1 box / 1 tablet in 1 pouch70518-4628-0Remedyrepack24 April 2026

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 28 June 1978Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Bromocriptine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Bromocriptine 2.5 mg tablet 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.