donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-659
Product ID 43063-659_4139fb45-0028-88cf-e063-6294a90af3db
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 43063659
Hyphenated Format 43063-659

Supplemental Identifiers

RxCUI
997223
UPC
0343063659908
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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-659-30)
source: ndc

Packages (1)

43063-659-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-659-30)

Ingredients (1)

donepezil hydrochloride (10 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": "4139fb45-0028-88cf-e063-6294a90af3db", "openfda": {"upc": ["0343063659908"], "unii": ["3O2T2PJ89D"], "rxcui": ["997223"], "spl_set_id": ["2be9f49d-e7db-4846-e054-00144ff8d46c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-659-30)", "package_ndc": "43063-659-30", "marketing_start_date": "20160304"}], "brand_name": "Donepezil Hydrochloride", "product_id": "43063-659_4139fb45-0028-88cf-e063-6294a90af3db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "43063-659", "generic_name": "Donepezil Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA201146", "marketing_category": "ANDA", "marketing_start_date": "20120817", "listing_expiration_date": "20261231"}