Medicine
Galantamine 12 mg tablet
Galantamine 12 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
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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Galantamine
- Brand
- Sold under the generic name
- Strength
- 12 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 4000 tablets, 60 tablets, 1000 tablets and 4 more
- Manufacturers
- Aurobindo PharmaIndiaGolden State Medical SupplyRising Pharma HoldingsSlate Run PharmaceuticalsUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06DA04 Galantamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 February 2009
- Identifiers
- RxCUI 310436, 310437, 579148DailyMed set ID 4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc, 56f365e5-0a23-4f69-e054-00144ff8d46c, 10497273-d907-0514-e063-6294a90a1362 +2NDC 65862-460, 70436-006, 24979-724 +2Application ANDA090957, ANDA077604
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 |
|---|---|---|---|
| 4000 tablet, film coated in 1 bottle | 65862-460-49 | Aurobindo PharmaIndia | 29 March 2011 |
| 60 tablet, film coated in 1 bottle | 65862-460-60 | Aurobindo PharmaIndia | 29 March 2011 |
| 1000 tablet, film coated in 1 bottle | 65862-460-99 | Aurobindo PharmaIndia | 29 March 2011 |
| 60 tablet, film coated in 1 bottle | 57237-051-60 | Rising Pharma Holdings | 29 March 2011 |
| 60 tablet, film coated in 1 bottle | 70436-006-06 | Slate Run Pharmaceuticals | 2 August 2017 |
| 60 tablet, film coated in 1 bottle | 24979-724-04 | Upsher-Smith Laboratories | 6 March 2024 |
| 60 tablet, film coated in 1 bottle | 51407-908-60 | Golden State Medical Supply | 15 April 2024 |
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 February 2001 | 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 Galantamine
Clinical summary
Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. It is available as tablets, extended-release capsules and oral solution. MedsAcross supplies Galantamine 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 GalantamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Galantamine prescribing information (Slate Run Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Galantamine 12 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.