donepezil hydrochloride

Generic: donepezil hydrochloride

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

Drug Facts

Product Profile

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

donepezil hydrochloride 23 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-527
Product ID 68180-527_f8867ea9-a608-4b0f-9052-fa5c44d7e7c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202782
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180527
Hyphenated Format 68180-527

Supplemental Identifiers

RxCUI
1100184
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 ANDA202782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68180-527-06)
  • 90 TABLET in 1 BOTTLE (68180-527-09)
source: ndc

Packages (2)

68180-527-06 30 TABLET in 1 BOTTLE (68180-527-06) 68180-527-09 90 TABLET in 1 BOTTLE (68180-527-09)

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": "f8867ea9-a608-4b0f-9052-fa5c44d7e7c2", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["1100184"], "spl_set_id": ["03e26183-3e07-45e8-a414-a8bad32483e2"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-527-06)", "package_ndc": "68180-527-06", "marketing_start_date": "20151221"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68180-527-09)", "package_ndc": "68180-527-09", "marketing_start_date": "20151221"}], "brand_name": "DONEPEZIL HYDROCHLORIDE", "product_id": "68180-527_f8867ea9-a608-4b0f-9052-fa5c44d7e7c2", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "68180-527", "generic_name": "DONEPEZIL HYDROCHLORIDE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DONEPEZIL HYDROCHLORIDE", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA202782", "marketing_category": "ANDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}