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 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-042
Product ID 59651-042_ef77c7dd-a65f-4adc-a0d9-a93779b459a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209694
Listing Expiration 2026-12-31
Marketing Start 2024-10-18

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651042
Hyphenated Format 59651-042

Supplemental Identifiers

RxCUI
1807894 1807917
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 ANDA209694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60)
source: ndc

Packages (1)

59651-042-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60)

Ingredients (1)

metformin hydrochloride (500 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": "ef77c7dd-a65f-4adc-a0d9-a93779b459a0", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["ef77c7dd-a65f-4adc-a0d9-a93779b459a0"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60)", "package_ndc": "59651-042-60", "marketing_start_date": "20241018"}], "brand_name": "Metformin Hydrochloride", "product_id": "59651-042_ef77c7dd-a65f-4adc-a0d9-a93779b459a0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "59651-042", "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": "500 mg/1"}], "application_number": "ANDA209694", "marketing_category": "ANDA", "marketing_start_date": "20241018", "listing_expiration_date": "20261231"}