Memantine and Donepezil

FDA Drug Profile — Memantine and Donepezil Hydrochlorides Extended-release, Memantine and Donepezil

Memantine and Donepezil is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including Memantine and Donepezil Hydrochlorides Extended-release, Memantine and Donepezil. Available dosage form: capsule, extended release.

Drug Details

Generic Name
Memantine and Donepezil
Brand Names
Memantine and Donepezil Hydrochlorides Extended-release, Memantine and Donepezil
Application Number
ANDA208328
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
7
Dosage Forms
CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
MEMANTINE HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. ( 1 )