Medicine
Memantine and Donepezil Hydrochlorides Extended-release 10 mg/28 mg extended-release capsule
Memantine and Donepezil Hydrochlorides Extended-release 10 mg/28 mg extended-release capsule is a prescription medicine containing Donepezil and Memantine for oral use, marketed by Amneal Pharmaceuticals NY, 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 20º to 25°C (68º to 77°F), excursions permitted between 15° to 30ºC…
Key facts
- Active ingredient (INN)
- Donepezil and Memantine
- Brand
- Memantine and Donepezil Hydrochlorides Extended-release
- Strength
- 10 mg/28 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules
- Marketing authorisation holder
- Amneal Pharmaceuticals NY
- Manufacturers
- Amneal Pharmaceuticals NYAvKARE
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25°C (68º to 77°F), excursions permitted between 15° to 30ºC (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06DA52 Donepezil and Memantine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 February 2017
- Identifiers
- RxCUI 1599803, 1599805, 1805420 +1DailyMed set ID 2335950c-be3b-4248-ad04-e9763aee47d2, 2d821427-34ca-3c5d-e063-6394a90a9013NDC 69238-1247, 73190-004Application ANDA208328
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule, extended release in 1 bottle | 69238-1247-3 | Amneal Pharmaceuticals NY | 1 February 2017 |
| 90 capsule, extended release in 1 bottle | 69238-1247-9 | Amneal Pharmaceuticals NY | 1 February 2017 |
| 30 capsule, extended release in 1 bottle | 73190-004-30 | AvKARE | 6 February 2025 |
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 23 December 2014 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| 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
Alternatives
Other makers and brands of Donepezil and Memantine 10 mg/28 mg extended-release capsule.
Other strengths and forms of Donepezil and Memantine
Clinical summary
Donepezil and Memantine is a fixed-dose combination of a cholinesterase inhibitor and a N-methyl-D-aspartate receptor antagonist. It is available as extended-release capsules and capsules for oral use. MedsAcross supplies Donepezil and Memantine 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 Donepezil and MemantineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Namzaric prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Memantine and Donepezil Hydrochlorides Extended-release 10 mg/28 mg extended-release 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.