donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 23 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-948
Product ID 71205-948_b974cd85-fbe8-40e4-89a7-b6c6845172e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203104
Listing Expiration 2026-12-31
Marketing Start 2015-03-01

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205948
Hyphenated Format 71205-948

Supplemental Identifiers

RxCUI
1100184
UPC
0371205948306
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 ANDA203104 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (71205-948-00)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-948-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71205-948-55)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-948-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-948-90)
source: ndc

Packages (5)

71205-948-00 100 TABLET, FILM COATED in 1 BOTTLE (71205-948-00) 71205-948-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-948-30) 71205-948-55 500 TABLET, FILM COATED in 1 BOTTLE (71205-948-55) 71205-948-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-948-60) 71205-948-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-948-90)

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": "b974cd85-fbe8-40e4-89a7-b6c6845172e1", "openfda": {"upc": ["0371205948306"], "unii": ["3O2T2PJ89D"], "rxcui": ["1100184"], "spl_set_id": ["32709bda-53d0-4d57-9f0b-3e1f28e39f25"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71205-948-00)", "package_ndc": "71205-948-00", "marketing_start_date": "20201119"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-948-30)", "package_ndc": "71205-948-30", "marketing_start_date": "20201119"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71205-948-55)", "package_ndc": "71205-948-55", "marketing_start_date": "20201119"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-948-60)", "package_ndc": "71205-948-60", "marketing_start_date": "20201119"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-948-90)", "package_ndc": "71205-948-90", "marketing_start_date": "20201119"}], "brand_name": "Donepezil Hydrochloride", "product_id": "71205-948_b974cd85-fbe8-40e4-89a7-b6c6845172e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "71205-948", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA203104", "marketing_category": "ANDA", "marketing_start_date": "20150301", "listing_expiration_date": "20261231"}