donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-248
Product ID 29300-248_88d3f867-45f4-42fb-93f8-235c2f594760
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203656
Listing Expiration 2026-12-31
Marketing Start 2016-06-23

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300248
Hyphenated Format 29300-248

Supplemental Identifiers

RxCUI
997220 997223 997226 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 ANDA203656 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-13)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-19)
source: ndc

Packages (4)

29300-248-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-01) 29300-248-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-10) 29300-248-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-13) 29300-248-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-19)

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": "88d3f867-45f4-42fb-93f8-235c2f594760", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997220", "997223", "997226", "997229"], "spl_set_id": ["1a8906ce-96dc-4bc8-81c1-5db67a187aac"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-01)", "package_ndc": "29300-248-01", "marketing_start_date": "20180228"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-10)", "package_ndc": "29300-248-10", "marketing_start_date": "20180228"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-13)", "package_ndc": "29300-248-13", "marketing_start_date": "20180228"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-19)", "package_ndc": "29300-248-19", "marketing_start_date": "20180228"}], "brand_name": "donepezil hydrochloride", "product_id": "29300-248_88d3f867-45f4-42fb-93f8-235c2f594760", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "29300-248", "generic_name": "donepezil hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "donepezil hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203656", "marketing_category": "ANDA", "marketing_start_date": "20160623", "listing_expiration_date": "20261231"}