donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-019
Product ID 71209-019_e33aac76-604d-43cb-8be4-d58ce3b2b6f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204609
Listing Expiration 2026-12-31
Marketing Start 2017-01-30

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209019
Hyphenated Format 71209-019

Supplemental Identifiers

RxCUI
997223 997229
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 ANDA204609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71209-019-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71209-019-04)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (71209-019-11)
source: ndc

Packages (3)

71209-019-01 30 TABLET, FILM COATED in 1 BOTTLE (71209-019-01) 71209-019-04 90 TABLET, FILM COATED in 1 BOTTLE (71209-019-04) 71209-019-11 1000 TABLET, FILM COATED in 1 BOTTLE (71209-019-11)

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": "e33aac76-604d-43cb-8be4-d58ce3b2b6f8", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["37aa1285-774a-4714-a4af-4e3fa9fa7f55"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71209-019-01)", "package_ndc": "71209-019-01", "marketing_start_date": "20181124"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71209-019-04)", "package_ndc": "71209-019-04", "marketing_start_date": "20181124"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (71209-019-11)", "package_ndc": "71209-019-11", "marketing_start_date": "20181124"}], "brand_name": "DONEPEZIL HYDROCHLORIDE", "product_id": "71209-019_e33aac76-604d-43cb-8be4-d58ce3b2b6f8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "71209-019", "generic_name": "donepezil hydrochloride", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DONEPEZIL HYDROCHLORIDE", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA204609", "marketing_category": "ANDA", "marketing_start_date": "20170130", "listing_expiration_date": "20261231"}