donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

donepezil hydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6478
Product ID 0904-6478_cb092ac4-5569-4fbf-88bd-8b3037a946fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090686
Listing Expiration 2027-12-31
Marketing Start 2011-05-28

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046478
Hyphenated Format 0904-6478

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 ANDA090686 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6478-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6478-61 100 BLISTER PACK in 1 CARTON (0904-6478-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "cb092ac4-5569-4fbf-88bd-8b3037a946fb", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["c777ddc9-0b61-4d6f-95d6-818ba1861d62"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6478-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6478-61", "marketing_start_date": "20110528"}], "brand_name": "Donepezil Hydrochloride", "product_id": "0904-6478_cb092ac4-5569-4fbf-88bd-8b3037a946fb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0904-6478", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090686", "marketing_category": "ANDA", "marketing_start_date": "20110528", "listing_expiration_date": "20271231"}