donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

donepezil hydrochloride 5 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-139
Product ID 50228-139_652d4a32-9c92-43df-be8a-a91cfaf61c3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203907
Listing Expiration 2027-12-31
Marketing Start 2014-10-29

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228139
Hyphenated Format 50228-139

Supplemental Identifiers

RxCUI
997223 997229
UPC
0350228140300 0350228139106 0350228139304
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 ANDA203907 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-139-30)
source: ndc

Packages (2)

50228-139-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10) 50228-139-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-139-30)

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": "652d4a32-9c92-43df-be8a-a91cfaf61c3a", "openfda": {"upc": ["0350228140300", "0350228139106", "0350228139304"], "unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["6e9aacf9-abb6-4dec-9a8d-4eabf934d512"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10)", "package_ndc": "50228-139-10", "marketing_start_date": "20141029"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-139-30)", "package_ndc": "50228-139-30", "marketing_start_date": "20141029"}], "brand_name": "Donepezil Hydrochloride", "product_id": "50228-139_652d4a32-9c92-43df-be8a-a91cfaf61c3a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "50228-139", "generic_name": "Donepezil Hydrochloride", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203907", "marketing_category": "ANDA", "marketing_start_date": "20141029", "listing_expiration_date": "20271231"}