donepezil

Generic: donepezil hydrochloride

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

Drug Facts

Product Profile

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

donepezil hydrochloride 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4380
Product ID 70518-4380_38f267b8-b95d-f393-e063-6294a90ad5be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203034
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184380
Hyphenated Format 70518-4380

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 (source: ndc)
Generic Name donepezil hydrochloride (source: ndc)
Application Number ANDA203034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0)
source: ndc

Packages (1)

70518-4380-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0)

Ingredients (1)

donepezil hydrochloride (5 mg/1)

Linked Drug Pages (1)

Donepezil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38f267b8-b95d-f393-e063-6294a90ad5be", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997229"], "spl_set_id": ["37fc6638-4a63-4582-a64c-3525f8ed7ef2"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0)", "package_ndc": "70518-4380-0", "marketing_start_date": "20250701"}], "brand_name": "Donepezil", "product_id": "70518-4380_38f267b8-b95d-f393-e063-6294a90ad5be", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "70518-4380", "generic_name": "Donepezil hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203034", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}