metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-549
Product ID 59651-549_8d4b8620-5e99-4d12-b4f2-e9967b627b57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079118
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651549
Hyphenated Format 59651-549

Supplemental Identifiers

RxCUI
860975 860981
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 ANDA079118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-05)
source: ndc

Packages (2)

59651-549-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-01) 59651-549-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-05)

Ingredients (1)

metformin hydrochloride (750 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": "8d4b8620-5e99-4d12-b4f2-e9967b627b57", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["8d4b8620-5e99-4d12-b4f2-e9967b627b57"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-01)", "package_ndc": "59651-549-01", "marketing_start_date": "20240415"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-549-05)", "package_ndc": "59651-549-05", "marketing_start_date": "20240415"}], "brand_name": "Metformin Hydrochloride", "product_id": "59651-549_8d4b8620-5e99-4d12-b4f2-e9967b627b57", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "59651-549", "generic_name": "Metformin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA079118", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}