donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 5 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-778
Product ID 16571-778_b963d4b7-66f3-47d7-8671-7412d49e6cb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090056
Listing Expiration 2026-12-31
Marketing Start 2011-05-31

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571778
Hyphenated Format 16571-778

Supplemental Identifiers

RxCUI
997223 997229
UPC
0316571778034 0316571779031
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 ANDA090056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16571-778-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16571-778-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16571-778-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-778-50)
source: ndc

Packages (4)

16571-778-03 30 TABLET, FILM COATED in 1 BOTTLE (16571-778-03) 16571-778-09 90 TABLET, FILM COATED in 1 BOTTLE (16571-778-09) 16571-778-10 1000 TABLET, FILM COATED in 1 BOTTLE (16571-778-10) 16571-778-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-778-50)

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": "b963d4b7-66f3-47d7-8671-7412d49e6cb3", "openfda": {"upc": ["0316571778034", "0316571779031"], "unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["86b0c5a0-ff3c-4840-a4ac-82af922d58bf"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16571-778-03)", "package_ndc": "16571-778-03", "marketing_start_date": "20110531"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16571-778-09)", "package_ndc": "16571-778-09", "marketing_start_date": "20110531"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-778-10)", "package_ndc": "16571-778-10", "marketing_start_date": "20110531"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-778-50)", "package_ndc": "16571-778-50", "marketing_start_date": "20110531"}], "brand_name": "Donepezil Hydrochloride", "product_id": "16571-778_b963d4b7-66f3-47d7-8671-7412d49e6cb3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "16571-778", "generic_name": "Donepezil Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil Hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090056", "marketing_category": "ANDA", "marketing_start_date": "20110531", "listing_expiration_date": "20261231"}