memantine and donepezil hydrochlorides extended-release (69238-1248)

Drug Facts

Product Profile

Brand Name memantine and donepezil hydrochlorides extended-release

Generic Name memantine and donepezil

Labeler amneal pharmaceuticals ny llc

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

donepezil hydrochloride 10 mg/1, memantine hydrochloride 14 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1248

Product ID 69238-1248_acd577e1-312c-4d5a-85b5-bc50ef9de545

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208328

Listing Expiration 2026-12-31

Marketing Start 2017-02-01

Pharmacologic Class

Classes

cholinesterase inhibitor [epc] cholinesterase inhibitors [moa] n-methyl-d-aspartate receptor antagonist [epc] nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381248

Hyphenated Format 69238-1248

Supplemental Identifiers

RxCUI

1599803 1599805 1805420 1805425

UPC

0369238124897 0369238155396 0369238124798 0369238155297

UNII

JY0WD0UA60 3O2T2PJ89D

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name memantine and donepezil hydrochlorides extended-release (source: ndc)

Generic Name memantine and donepezil (source: ndc)

Application Number ANDA208328 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
14 mg/1

source: ndc

Packaging

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-3)
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-9)

source: ndc

Packages (2)

69238-1248-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-3) 69238-1248-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-9)

Ingredients (2)

donepezil hydrochloride (10 mg/1) memantine hydrochloride (14 mg/1)

Linked Drug Pages (1)

Memantine and Donepezil Hydrochlorides Extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "acd577e1-312c-4d5a-85b5-bc50ef9de545", "openfda": {"upc": ["0369238124897", "0369238155396", "0369238124798", "0369238155297"], "unii": ["JY0WD0UA60", "3O2T2PJ89D"], "rxcui": ["1599803", "1599805", "1805420", "1805425"], "spl_set_id": ["2335950c-be3b-4248-ad04-e9763aee47d2"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-3)", "package_ndc": "69238-1248-3", "marketing_start_date": "20170201"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1248-9)", "package_ndc": "69238-1248-9", "marketing_start_date": "20170201"}], "brand_name": "Memantine and Donepezil Hydrochlorides Extended-release", "product_id": "69238-1248_acd577e1-312c-4d5a-85b5-bc50ef9de545", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]", "N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "69238-1248", "generic_name": "Memantine and Donepezil", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine and Donepezil Hydrochlorides Extended-release", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}, {"name": "MEMANTINE HYDROCHLORIDE", "strength": "14 mg/1"}], "application_number": "ANDA208328", "marketing_category": "ANDA", "marketing_start_date": "20170201", "listing_expiration_date": "20261231"}