memantine and donepezil hydrochlorides

Generic: memantine and donepezil hydrochlorides

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine and donepezil hydrochlorides
Generic Name memantine and donepezil hydrochlorides
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

donepezil hydrochloride 10 mg/1, memantine hydrochloride 21 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-207
Product ID 62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208237
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

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 62559207
Hyphenated Format 62559-207

Supplemental Identifiers

RxCUI
1805420
UPC
0362559207300
UNII
3O2T2PJ89D JY0WD0UA60

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 (source: ndc)
Generic Name memantine and donepezil hydrochlorides (source: ndc)
Application Number ANDA208237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 21 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30)
source: ndc

Packages (1)

62559-207-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30)

Ingredients (2)

donepezil hydrochloride (10 mg/1) memantine hydrochloride (21 mg/1)

Linked Drug Pages (1)

MEMANTINE AND DONEPEZIL HYDROCHLORIDES ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd8d0e95-24ac-43e1-9d43-bb081b4f341e", "openfda": {"upc": ["0362559207300"], "unii": ["3O2T2PJ89D", "JY0WD0UA60"], "rxcui": ["1805420"], "spl_set_id": ["c42a995d-cd0f-466c-8f47-43c7f32d9675"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30)", "package_ndc": "62559-207-30", "marketing_start_date": "20250101"}], "brand_name": "MEMANTINE AND DONEPEZIL HYDROCHLORIDES", "product_id": "62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e", "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": "62559-207", "generic_name": "MEMANTINE AND DONEPEZIL HYDROCHLORIDES", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEMANTINE AND DONEPEZIL HYDROCHLORIDES", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}, {"name": "MEMANTINE HYDROCHLORIDE", "strength": "21 mg/1"}], "application_number": "ANDA208237", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}