donepezil

Generic: donepezil hydrochloride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil
Generic Name donepezil hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-119
Product ID 82009-119_4533e92e-9af5-cce3-e063-6294a90ac926
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203034
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009119
Hyphenated Format 82009-119

Supplemental Identifiers

RxCUI
997223 997229
UPC
0382009119052 0382009120058
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 (source: ndc)
Generic Name donepezil hydrochloride (source: ndc)
Application Number ANDA203034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (82009-119-05)
source: ndc

Packages (1)

82009-119-05 500 TABLET in 1 BOTTLE (82009-119-05)

Ingredients (1)

donepezil hydrochloride (5 mg/1)

Linked Drug Pages (1)

Donepezil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4533e92e-9af5-cce3-e063-6294a90ac926", "openfda": {"upc": ["0382009119052", "0382009120058"], "unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (82009-119-05)", "package_ndc": "82009-119-05", "marketing_start_date": "20230719"}], "brand_name": "Donepezil", "product_id": "82009-119_4533e92e-9af5-cce3-e063-6294a90ac926", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "82009-119", "generic_name": "Donepezil hydrochloride", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203034", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}