donepezil hydrochloride

Generic: donepezil hydrochloride

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

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler hisun pharmaceuticals usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-119
Product ID 42658-119_2c703e82-e970-a97e-e063-6294a90a1639
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205269
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658119
Hyphenated Format 42658-119

Supplemental Identifiers

RxCUI
997220 997226
UPC
0342658120083 0342658119087 0342658119513 0342658120014 0342658119049 0342658119018 0342658120519 0342658120045
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 ANDA205269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-01)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-04)
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08)
  • 3 BLISTER PACK in 1 CARTON (42658-119-51) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (4)

42658-119-01 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-01) 42658-119-04 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-04) 42658-119-08 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08) 42658-119-51 3 BLISTER PACK in 1 CARTON (42658-119-51) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "2c703e82-e970-a97e-e063-6294a90a1639", "openfda": {"upc": ["0342658120083", "0342658119087", "0342658119513", "0342658120014", "0342658119049", "0342658119018", "0342658120519", "0342658120045"], "unii": ["3O2T2PJ89D"], "rxcui": ["997220", "997226"], "spl_set_id": ["8d682a51-31d0-43e6-9fab-6eb5219f5a41"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-01)", "package_ndc": "42658-119-01", "marketing_start_date": "20250101"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-04)", "package_ndc": "42658-119-04", "marketing_start_date": "20250101"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42658-119-08)", "package_ndc": "42658-119-08", "marketing_start_date": "20250101"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (42658-119-51)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "42658-119-51", "marketing_start_date": "20250101"}], "brand_name": "Donepezil Hydrochloride", "product_id": "42658-119_2c703e82-e970-a97e-e063-6294a90a1639", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "42658-119", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205269", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}