donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1476
Product ID 67046-1476_2d01f6be-2eb0-8f47-e063-6394a90a56af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090056
Listing Expiration 2026-12-31
Marketing Start 2025-01-31

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461476
Hyphenated Format 67046-1476

Supplemental Identifiers

RxCUI
997229
UNII
3O2T2PJ89D

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 donepezil hydrochloride (source: ndc)
Generic Name donepezil hydrochloride (source: ndc)
Application Number ANDA090056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1476-3)
source: ndc

Packages (1)

67046-1476-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1476-3)

Ingredients (1)

donepezil hydrochloride (5 mg/1)

Linked Drug Pages (1)

Donepezil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d01f6be-2eb0-8f47-e063-6394a90a56af", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997229"], "spl_set_id": ["2d01fb96-c825-fad5-e063-6394a90ac6cc"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1476-3)", "package_ndc": "67046-1476-3", "marketing_start_date": "20250131"}], "brand_name": "Donepezil Hydrochloride", "product_id": "67046-1476_2d01f6be-2eb0-8f47-e063-6394a90a56af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "67046-1476", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090056", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}