donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: aci healthcare usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler aci healthcare usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

donepezil hydrochloride 10 mg/1

Manufacturer
ACI Healthcare USA, Inc.

Identifiers & Regulatory

Product NDC 71093-128
Product ID 71093-128_a4736add-da84-411f-8e6f-9de67bf467f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078662
Listing Expiration 2026-12-31
Marketing Start 2021-06-29

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71093128
Hyphenated Format 71093-128

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 ANDA078662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71093-128-01)
  • 90 TABLET in 1 BOTTLE (71093-128-03)
  • 500 TABLET in 1 BOTTLE (71093-128-05)
  • 1000 TABLET in 1 BOTTLE (71093-128-06)
source: ndc

Packages (4)

71093-128-01 30 TABLET in 1 BOTTLE (71093-128-01) 71093-128-03 90 TABLET in 1 BOTTLE (71093-128-03) 71093-128-05 500 TABLET in 1 BOTTLE (71093-128-05) 71093-128-06 1000 TABLET in 1 BOTTLE (71093-128-06)

Ingredients (1)

donepezil hydrochloride (10 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": "a4736add-da84-411f-8e6f-9de67bf467f8", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["297e86e8-d248-4cc9-9d9c-2ef9efb4414d"], "manufacturer_name": ["ACI Healthcare USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71093-128-01)", "package_ndc": "71093-128-01", "marketing_start_date": "20210629"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71093-128-03)", "package_ndc": "71093-128-03", "marketing_start_date": "20210629"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71093-128-05)", "package_ndc": "71093-128-05", "marketing_start_date": "20210629"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71093-128-06)", "package_ndc": "71093-128-06", "marketing_start_date": "20210629"}], "brand_name": "Donepezil Hydrochloride", "product_id": "71093-128_a4736add-da84-411f-8e6f-9de67bf467f8", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "71093-128", "generic_name": "Donepezil Hydrochloride", "labeler_name": "ACI Healthcare USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078662", "marketing_category": "ANDA", "marketing_start_date": "20210629", "listing_expiration_date": "20261231"}