donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4392
Product ID 70518-4392_3a0b2193-f0a9-26aa-e063-6294a90a8368
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090056
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184392
Hyphenated Format 70518-4392

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
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4392-0)
source: ndc

Packages (1)

70518-4392-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4392-0)

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": "3a0b2193-f0a9-26aa-e063-6294a90a8368", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997229"], "spl_set_id": ["de96349a-5fee-4de9-921c-e453d44b3203"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4392-0)", "package_ndc": "70518-4392-0", "marketing_start_date": "20250715"}], "brand_name": "Donepezil Hydrochloride", "product_id": "70518-4392_3a0b2193-f0a9-26aa-e063-6294a90a8368", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "70518-4392", "generic_name": "Donepezil Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "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": "20250715", "listing_expiration_date": "20261231"}