donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler edenbridge pharmaceuticals llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 23 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-954
Product ID 42799-954_19147d81-49ac-463e-8643-26dace803ea5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203713
Listing Expiration 2026-12-31
Marketing Start 2016-02-19

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799954
Hyphenated Format 42799-954

Supplemental Identifiers

RxCUI
1100184
UPC
0342799954028 0342799954011
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 ANDA203713 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)
source: ndc

Packages (2)

42799-954-01 30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01) 42799-954-02 90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)

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": "19147d81-49ac-463e-8643-26dace803ea5", "openfda": {"upc": ["0342799954028", "0342799954011"], "unii": ["3O2T2PJ89D"], "rxcui": ["1100184"], "spl_set_id": ["11404dc3-1bde-4d4e-8386-006b67ee19dd"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)", "package_ndc": "42799-954-01", "marketing_start_date": "20231205"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)", "package_ndc": "42799-954-02", "marketing_start_date": "20231205"}], "brand_name": "Donepezil hydrochloride", "product_id": "42799-954_19147d81-49ac-463e-8643-26dace803ea5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "42799-954", "generic_name": "Donepezil hydrochloride", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA203713", "marketing_category": "ANDA", "marketing_start_date": "20160219", "listing_expiration_date": "20261231"}