United States· US:69238-1553_acd577e1-312c-4d5a-85b5-bc50ef9de545
Memantine and Donepezil Hydrochlorides Extended-release
A donepezil and memantine product containing memantine hydrochloride; donepezil hydrochloride, registered in United States by Amneal Pharmaceuticals NY LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Country
- United States (US)
- ATC code
- N06DA52
- ATC class
- Donepezil and memantine
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc11692381553330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-3)
- ndc11692381553990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-9)
- ndc1169238-1553-3
- ndc1169238-1553-9
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Donepezil and memantine in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Cyprus · Alzkar
- Spain · Dezipar, Domex
- Greece · Domenta, Nuoalz
- Croatia · Alzkar, Amzelix
- Italy · Cevedalo
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/dd7ca1f8-ac57-4186-abe8-dca7403c12fb GET /v1/drugs/dd7ca1f8-ac57-4186-abe8-dca7403c12fb?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "21; 10",
"substance": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"productndc": "69238-1553",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA208328",
"marketing_category": "ANDA"
}See everything about donepezil and memantine.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.