donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 23 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-004
Product ID 24979-004_e1f7708c-55a7-4201-86c6-089ff0cce422
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203104
Listing Expiration 2026-12-31
Marketing Start 2015-03-01

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979004
Hyphenated Format 24979-004

Supplemental Identifiers

RxCUI
1100184
UPC
0324979004068 0324979004075
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 ANDA203104 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (24979-004-07)
source: ndc

Packages (2)

Ingredients (1)

donepezil hydrochloride (23 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "e1f7708c-55a7-4201-86c6-089ff0cce422", "openfda": {"upc": ["0324979004068", "0324979004075"], "unii": ["3O2T2PJ89D"], "rxcui": ["1100184"], "spl_set_id": ["12a755c5-1ad9-43d1-832a-eb2ff17bd693"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06)", "package_ndc": "24979-004-06", "marketing_start_date": "20150301"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (24979-004-07)", "package_ndc": "24979-004-07", "marketing_start_date": "20150922"}], "brand_name": "Donepezil Hydrochloride", "product_id": "24979-004_e1f7708c-55a7-4201-86c6-089ff0cce422", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "24979-004", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA203104", "marketing_category": "ANDA", "marketing_start_date": "20150301", "listing_expiration_date": "20261231"}