metformin hydrochloride

Generic: metformin hydrochloride

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler marksans pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-131
Product ID 25000-131_71607f0f-8bd5-471e-9d32-ed7b746753d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090888
Listing Expiration 2026-12-31
Marketing Start 2012-06-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000131
Hyphenated Format 25000-131

Supplemental Identifiers

RxCUI
861004 861007 861010
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 ANDA090888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (25000-131-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (25000-131-12)
  • 1800 TABLET, FILM COATED in 1 BAG (25000-131-52)
  • 1 BAG in 1 BOX (25000-131-98) / 9680 TABLET, FILM COATED in 1 BAG
source: ndc

Packages (4)

25000-131-03 30 TABLET, FILM COATED in 1 BOTTLE (25000-131-03) 25000-131-12 500 TABLET, FILM COATED in 1 BOTTLE (25000-131-12) 25000-131-52 1800 TABLET, FILM COATED in 1 BAG (25000-131-52) 25000-131-98 1 BAG in 1 BOX (25000-131-98) / 9680 TABLET, FILM COATED in 1 BAG

Ingredients (1)

metformin hydrochloride (850 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": "71607f0f-8bd5-471e-9d32-ed7b746753d7", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["b8004451-7b26-425b-b5ea-cbb1b08e30e3"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (25000-131-03)", "package_ndc": "25000-131-03", "marketing_start_date": "20120601"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (25000-131-12)", "package_ndc": "25000-131-12", "marketing_start_date": "20120601"}, {"sample": false, "description": "1800 TABLET, FILM COATED in 1 BAG (25000-131-52)", "package_ndc": "25000-131-52", "marketing_start_date": "20120601"}, {"sample": false, "description": "1 BAG in 1 BOX (25000-131-98)  / 9680 TABLET, FILM COATED in 1 BAG", "package_ndc": "25000-131-98", "marketing_start_date": "20120601"}], "brand_name": "Metformin Hydrochloride", "product_id": "25000-131_71607f0f-8bd5-471e-9d32-ed7b746753d7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "25000-131", "generic_name": "Metformin Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA090888", "marketing_category": "ANDA", "marketing_start_date": "20120601", "listing_expiration_date": "20261231"}