metformin hydrochloride

Generic: metformin hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7187
Product ID 0378-7187_d1f3ad9f-8f0a-487f-9aad-1b77afe5a03e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075973
Listing Expiration 2026-12-31
Marketing Start 2010-06-03

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787187
Hyphenated Format 0378-7187

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0303787187057 0303787185053 0303787186050
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 ANDA075973 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7187-05)
source: ndc

Packages (1)

0378-7187-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7187-05)

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": "d1f3ad9f-8f0a-487f-9aad-1b77afe5a03e", "openfda": {"upc": ["0303787187057", "0303787185053", "0303787186050"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["4f70f907-08d5-4c2e-a4be-32c6124faa7b"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7187-05)", "package_ndc": "0378-7187-05", "marketing_start_date": "20100603"}], "brand_name": "Metformin Hydrochloride", "product_id": "0378-7187_d1f3ad9f-8f0a-487f-9aad-1b77afe5a03e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0378-7187", "generic_name": "metformin hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA075973", "marketing_category": "ANDA", "marketing_start_date": "20100603", "listing_expiration_date": "20261231"}