donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-7951
Product ID 0615-7951_4d853615-465a-436e-b50d-c7bfea279919
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201146
Listing Expiration 2026-12-31
Marketing Start 2012-08-17

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06157951
Hyphenated Format 0615-7951

Supplemental Identifiers

RxCUI
997223 997229
UNII
3O2T2PJ89D

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 ANDA201146 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39)
source: ndc

Packages (2)

0615-7951-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05) 0615-7951-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39)

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": "4d853615-465a-436e-b50d-c7bfea279919", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["ac857917-74db-4591-be9f-d1c822c68c81"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05)", "package_ndc": "0615-7951-05", "marketing_start_date": "20120817"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39)", "package_ndc": "0615-7951-39", "marketing_start_date": "20120817"}], "brand_name": "Donepezil Hydrochloride", "product_id": "0615-7951_4d853615-465a-436e-b50d-c7bfea279919", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0615-7951", "generic_name": "Donepezil Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA201146", "marketing_category": "ANDA", "marketing_start_date": "20120817", "listing_expiration_date": "20261231"}