donepezil hydrochloride

Generic: donepezil hydrochloride

Labeler: dr. reddys laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name donepezil hydrochloride
Generic Name donepezil hydrochloride
Labeler dr. reddys laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

donepezil hydrochloride 23 mg/1

Manufacturer
Dr. Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-302
Product ID 55111-302_0df6bfb2-4604-2035-9677-06c125e77bb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202723
Listing Expiration 2026-12-31
Marketing Start 2025-08-20

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111302
Hyphenated Format 55111-302

Supplemental Identifiers

RxCUI
1100184
UPC
0355111302308
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 ANDA202723 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-302-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (55111-302-90)
source: ndc

Packages (2)

55111-302-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-302-30) 55111-302-90 90 TABLET, FILM COATED in 1 BOTTLE (55111-302-90)

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": "0df6bfb2-4604-2035-9677-06c125e77bb9", "openfda": {"upc": ["0355111302308"], "unii": ["3O2T2PJ89D"], "rxcui": ["1100184"], "spl_set_id": ["7c0d3bcb-157d-0414-64ee-055bc614d190"], "manufacturer_name": ["Dr. Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-302-30)", "package_ndc": "55111-302-30", "marketing_start_date": "20250820"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (55111-302-90)", "package_ndc": "55111-302-90", "marketing_start_date": "20250820"}], "brand_name": "Donepezil hydrochloride", "product_id": "55111-302_0df6bfb2-4604-2035-9677-06c125e77bb9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "55111-302", "generic_name": "Donepezil hydrochloride", "labeler_name": "Dr. Reddys Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Donepezil hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "23 mg/1"}], "application_number": "ANDA202723", "marketing_category": "ANDA", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}