donepezil hydrochloride (33342-061)

Drug Facts

Product Profile

Brand Name donepezil hydrochloride

Generic Name donepezil hydrochloride

Labeler macleods pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

donepezil hydrochloride 23 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-061

Product ID 33342-061_4bf742a3-3c8f-4bd3-b973-54370cbef345

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202631

Listing Expiration 2026-12-31

Marketing Start 2014-01-23

Pharmacologic Class

Classes

cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342061

Hyphenated Format 33342-061

Supplemental Identifiers

RxCUI

997220 997223 997226 997229 1100184

UPC

0333342061102 0333342061072 0333342030078 0333342027108 0333342027078 0333342029072 0333342029607 0333342027153 0333342028150 0333342030603

UNII

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 donepezil hydrochloride (source: ndc)

Generic Name donepezil hydrochloride (source: ndc)

Application Number ANDA202631 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

23 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (33342-061-07)
90 TABLET, FILM COATED in 1 BOTTLE (33342-061-10)
10 BLISTER PACK in 1 CARTON (33342-061-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (3)

33342-061-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-061-07) 33342-061-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-061-10) 33342-061-12 10 BLISTER PACK in 1 CARTON (33342-061-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

donepezil hydrochloride (23 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": "4bf742a3-3c8f-4bd3-b973-54370cbef345", "openfda": {"upc": ["0333342061102", "0333342061072", "0333342030078", "0333342027108", "0333342027078", "0333342029072", "0333342029607", "0333342027153", "0333342028150", "0333342030603"], "unii": ["3O2T2PJ89D"], "rxcui": ["997220", "997223", "997226", "997229", "1100184"], "spl_set_id": ["06dd25a5-1bf2-446d-ad75-ff9d55117660"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-061-07)", "package_ndc": "33342-061-07", "marketing_start_date": "20140123"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-061-10)", "package_ndc": "33342-061-10", "marketing_start_date": "20140123"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-061-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-061-12", "marketing_start_date": "20140123"}], "brand_name": "Donepezil Hydrochloride", "product_id": "33342-061_4bf742a3-3c8f-4bd3-b973-54370cbef345", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "33342-061", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA202631", "marketing_category": "ANDA", "marketing_start_date": "20140123", "listing_expiration_date": "20261231"}