donepezil hydrochloride

Generic: donepezil hydrochloride

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

Drug Facts

Product Profile

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

donepezil hydrochloride 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8208
Product ID 68788-8208_55faf13b-98bb-4ecf-9824-3f9e04c14912
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090056
Listing Expiration 2026-12-31
Marketing Start 2022-06-03

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888208
Hyphenated Format 68788-8208

Supplemental Identifiers

RxCUI
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 ANDA090056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8208-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8208-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8208-9)
source: ndc

Packages (3)

68788-8208-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8208-3) 68788-8208-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8208-6) 68788-8208-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8208-9)

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": "55faf13b-98bb-4ecf-9824-3f9e04c14912", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997229"], "spl_set_id": ["8138f616-83f3-4c47-84ef-1bce2db339f7"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8208-3)", "package_ndc": "68788-8208-3", "marketing_start_date": "20220603"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8208-6)", "package_ndc": "68788-8208-6", "marketing_start_date": "20220603"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8208-9)", "package_ndc": "68788-8208-9", "marketing_start_date": "20220603"}], "brand_name": "Donepezil Hydrochloride", "product_id": "68788-8208_55faf13b-98bb-4ecf-9824-3f9e04c14912", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "68788-8208", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090056", "marketing_category": "ANDA", "marketing_start_date": "20220603", "listing_expiration_date": "20261231"}