donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-325
Product ID 65862-325_3c956648-d46c-41e2-a2d9-8560846a7a32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090056
Listing Expiration 2026-12-31
Marketing Start 2011-05-31

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862325
Hyphenated Format 65862-325

Supplemental Identifiers

RxCUI
997223 997229
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 ANDA090056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-325-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-325-05)
  • 10 BLISTER PACK in 1 CARTON (65862-325-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-325-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-325-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-325-99)
source: ndc

Packages (6)

65862-325-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-325-01) 65862-325-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-325-05) 65862-325-10 10 BLISTER PACK in 1 CARTON (65862-325-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-325-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-325-30) 65862-325-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-325-90) 65862-325-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-325-99)

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": "3c956648-d46c-41e2-a2d9-8560846a7a32", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["3257494f-8f44-4978-b92d-bde87b2444b6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-325-01)", "package_ndc": "65862-325-01", "marketing_start_date": "20110531"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-325-05)", "package_ndc": "65862-325-05", "marketing_start_date": "20110531"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-325-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-325-10", "marketing_start_date": "20110531"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-325-30)", "package_ndc": "65862-325-30", "marketing_start_date": "20110531"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-325-90)", "package_ndc": "65862-325-90", "marketing_start_date": "20110531"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-325-99)", "package_ndc": "65862-325-99", "marketing_start_date": "20110531"}], "brand_name": "Donepezil Hydrochloride", "product_id": "65862-325_3c956648-d46c-41e2-a2d9-8560846a7a32", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "65862-325", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "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": "20110531", "listing_expiration_date": "20261231"}