donepezil hydrochloride (55111-356)

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 5 mg/1

Manufacturer

Dr. Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-356

Product ID 55111-356_d6af4584-b379-0cea-78b6-a493f88708c8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201001

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 55111356

Hyphenated Format 55111-356

Supplemental Identifiers

RxCUI

997223 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 ANDA201001 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED in 1 BOTTLE (55111-356-05)
1000 TABLET, FILM COATED in 1 BOTTLE (55111-356-10)
30 TABLET, FILM COATED in 1 BOTTLE (55111-356-30)
10 BLISTER PACK in 1 CARTON (55111-356-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-356-79)
90 TABLET, FILM COATED in 1 BOTTLE (55111-356-90)

source: ndc

Packages (5)

55111-356-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-356-05) 55111-356-10 1000 TABLET, FILM COATED in 1 BOTTLE (55111-356-10) 55111-356-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-356-30) 55111-356-78 10 BLISTER PACK in 1 CARTON (55111-356-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-356-79) 55111-356-90 90 TABLET, FILM COATED in 1 BOTTLE (55111-356-90)

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": "d6af4584-b379-0cea-78b6-a493f88708c8", "openfda": {"unii": ["3O2T2PJ89D"], "rxcui": ["997223", "997229"], "spl_set_id": ["4c9889fd-2cb3-02da-f034-46120acc38c3"], "manufacturer_name": ["Dr. Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-356-05)", "package_ndc": "55111-356-05", "marketing_start_date": "20110531"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (55111-356-10)", "package_ndc": "55111-356-10", "marketing_start_date": "20110531"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-356-30)", "package_ndc": "55111-356-30", "marketing_start_date": "20110531"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-356-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-356-79)", "package_ndc": "55111-356-78", "marketing_start_date": "20110531"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (55111-356-90)", "package_ndc": "55111-356-90", "marketing_start_date": "20110531"}], "brand_name": "Donepezil hydrochloride", "product_id": "55111-356_d6af4584-b379-0cea-78b6-a493f88708c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "55111-356", "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": "5 mg/1"}], "application_number": "ANDA201001", "marketing_category": "ANDA", "marketing_start_date": "20110531", "listing_expiration_date": "20261231"}