metformin hydrochloride (65841-811)

Drug Facts

Product Profile

Brand Name metformin hydrochloride

Generic Name metformin hydrochloride

Labeler zydus lifesciences limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer

Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-811

Product ID 65841-811_f845896f-d006-4f67-9de6-a734ca665025

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203686

Listing Expiration 2026-12-31

Marketing Start 2014-12-09

Pharmacologic Class

Classes

biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841811

Hyphenated Format 65841-811

Supplemental Identifiers

RxCUI

860975 861004 861010

UPC

0368382760012

UNII

786Z46389E

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 metformin hydrochloride (source: ndc)

Generic Name metformin hydrochloride (source: ndc)

Application Number ANDA203686 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1000 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (65841-811-01)
500 TABLET, FILM COATED in 1 BOTTLE (65841-811-05)
1000 TABLET, FILM COATED in 1 BOTTLE (65841-811-10)
90 TABLET, FILM COATED in 1 BOTTLE (65841-811-16)
100 BLISTER PACK in 1 CARTON (65841-811-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-811-30)

source: ndc

Packages (5)

65841-811-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-811-01) 65841-811-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-811-05) 65841-811-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-811-10) 65841-811-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-811-16) 65841-811-77 100 BLISTER PACK in 1 CARTON (65841-811-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-811-30)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "f845896f-d006-4f67-9de6-a734ca665025", "openfda": {"upc": ["0368382760012"], "unii": ["786Z46389E"], "rxcui": ["860975", "861004", "861010"], "spl_set_id": ["5043d03e-3c9d-4c96-b48d-187f02a1d27c"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-811-01)", "package_ndc": "65841-811-01", "marketing_start_date": "20141209"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-811-05)", "package_ndc": "65841-811-05", "marketing_start_date": "20141209"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-811-10)", "package_ndc": "65841-811-10", "marketing_start_date": "20141209"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-811-16)", "package_ndc": "65841-811-16", "marketing_start_date": "20141209"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (65841-811-77)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-811-30)", "package_ndc": "65841-811-77", "marketing_start_date": "20141209"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "65841-811_f845896f-d006-4f67-9de6-a734ca665025", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "65841-811", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA203686", "marketing_category": "ANDA", "marketing_start_date": "20141209", "listing_expiration_date": "20261231"}