donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

donepezil hydrochloride 23 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-194
Product ID 62756-194_65890f83-ea1b-4342-b403-6ebe155bc357
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204293
Listing Expiration 2026-12-31
Marketing Start 2015-06-17

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756194
Hyphenated Format 62756-194

Supplemental Identifiers

RxCUI
997223 997229 1100184
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 ANDA204293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-194-83)
source: ndc

Packages (3)

62756-194-18 1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18) 62756-194-81 90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81) 62756-194-83 30 TABLET, FILM COATED in 1 BOTTLE (62756-194-83)

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": "65890f83-ea1b-4342-b403-6ebe155bc357", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229", "1100184"], "spl_set_id": ["79ad107b-bb20-4ed3-89f0-d7c862f3957c"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18)", "package_ndc": "62756-194-18", "marketing_start_date": "20150617"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81)", "package_ndc": "62756-194-81", "marketing_start_date": "20150617"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-194-83)", "package_ndc": "62756-194-83", "marketing_start_date": "20150617"}], "brand_name": "Donepezil Hydrochloride", "product_id": "62756-194_65890f83-ea1b-4342-b403-6ebe155bc357", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "62756-194", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA204293", "marketing_category": "ANDA", "marketing_start_date": "20150617", "listing_expiration_date": "20261231"}