metformin hydrochloride

Generic: metformin hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7164
Product ID 0904-7164_bd51e808-5974-47ca-8b22-a828fc496b54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047164
Hyphenated Format 0904-7164

Supplemental Identifiers

RxCUI
861004 861007 861010
UNII
786Z46389E

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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7164-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7164-61 100 BLISTER PACK in 1 CARTON (0904-7164-61) / 1 TABLET in 1 BLISTER PACK

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": "bd51e808-5974-47ca-8b22-a828fc496b54", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["5e783025-bf6d-465e-bf58-bcd253afad2c"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7164-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7164-61", "marketing_start_date": "20190626"}], "brand_name": "Metformin Hydrochloride", "product_id": "0904-7164_bd51e808-5974-47ca-8b22-a828fc496b54", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0904-7164", "generic_name": "Metformin Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}