memantine and donepezil (33342-312)

Drug Facts

Product Profile

Brand Name memantine and donepezil

Generic Name memantine and donepezil

Labeler macleods pharmaceuticals limited

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-312

Product ID 33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208672

Listing Expiration 2026-12-31

Marketing Start 2025-07-15

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 33342312

Hyphenated Format 33342-312

Supplemental Identifiers

RxCUI

1599803 1599805

UPC

0333342312075 0333342312105 0333342313072 0333342313102

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 (source: ndc)

Generic Name memantine and donepezil (source: ndc)

Application Number ANDA208672 (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 (33342-312-07)
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10)
10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (3)

33342-312-07 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) 33342-312-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10) 33342-312-12 10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Memantine and Donepezil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3d9a23dc-8cbe-47c3-a048-70d86cb9dc14", "openfda": {"upc": ["0333342312075", "0333342312105", "0333342313072", "0333342313102"], "unii": ["JY0WD0UA60", "3O2T2PJ89D"], "rxcui": ["1599803", "1599805"], "spl_set_id": ["3d9a23dc-8cbe-47c3-a048-70d86cb9dc14"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07)", "package_ndc": "33342-312-07", "marketing_start_date": "20250715"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10)", "package_ndc": "33342-312-10", "marketing_start_date": "20250715"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-312-12)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-312-12", "marketing_start_date": "20250715"}], "brand_name": "Memantine and Donepezil", "product_id": "33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14", "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": "33342-312", "generic_name": "Memantine and Donepezil", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine and Donepezil", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}, {"name": "MEMANTINE HYDROCHLORIDE", "strength": "14 mg/1"}], "application_number": "ANDA208672", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}