donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

donepezil hydrochloride 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-295
Product ID 46708-295_f0627628-81b1-4b14-b49d-1e68b350146f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201724
Listing Expiration 2026-12-31
Marketing Start 2016-01-29

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708295
Hyphenated Format 46708-295

Supplemental Identifiers

RxCUI
997223 997229
UPC
0346708295301 0346708296308
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 ANDA201724 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 CARTON (46708-295-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-295-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-295-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-295-91)
source: ndc

Packages (4)

46708-295-10 100 TABLET, FILM COATED in 1 CARTON (46708-295-10) 46708-295-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-295-30) 46708-295-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-295-90) 46708-295-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-295-91)

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": "f0627628-81b1-4b14-b49d-1e68b350146f", "openfda": {"upc": ["0346708295301", "0346708296308"], "unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["bc570682-413b-46fb-a069-c2986884bfce"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (46708-295-10)", "package_ndc": "46708-295-10", "marketing_start_date": "20160129"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-295-30)", "package_ndc": "46708-295-30", "marketing_start_date": "20160129"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-295-90)", "package_ndc": "46708-295-90", "marketing_start_date": "20160129"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-295-91)", "package_ndc": "46708-295-91", "marketing_start_date": "20160129"}], "brand_name": "Donepezil Hydrochloride", "product_id": "46708-295_f0627628-81b1-4b14-b49d-1e68b350146f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "46708-295", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA201724", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20261231"}