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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-008
Product ID 65862-008_c535450c-12fd-478d-ad45-743c5badfc28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077095
Listing Expiration 2026-12-31
Marketing Start 2005-01-14

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862008
Hyphenated Format 65862-008

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0365862010018 0365862009012 0365862008015
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 ANDA077095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05)
  • 300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33)
  • 4500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45)
  • 50 TABLET, FILM COATED in 1 BOTTLE (65862-008-50)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-008-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99)
source: ndc

Packages (8)

65862-008-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01) 65862-008-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05) 65862-008-33 300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33) 65862-008-45 4500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45) 65862-008-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-008-50) 65862-008-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-008-60) 65862-008-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90) 65862-008-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99)

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": "c535450c-12fd-478d-ad45-743c5badfc28", "openfda": {"upc": ["0365862010018", "0365862009012", "0365862008015"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["4ac6d01a-af26-44e7-ae2e-3618de0080aa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01)", "package_ndc": "65862-008-01", "marketing_start_date": "20050114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05)", "package_ndc": "65862-008-05", "marketing_start_date": "20050114"}, {"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33)", "package_ndc": "65862-008-33", "marketing_start_date": "20050114"}, {"sample": false, "description": "4500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45)", "package_ndc": "65862-008-45", "marketing_start_date": "20050114"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (65862-008-50)", "package_ndc": "65862-008-50", "marketing_start_date": "20050114"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-008-60)", "package_ndc": "65862-008-60", "marketing_start_date": "20050114"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-008-90)", "package_ndc": "65862-008-90", "marketing_start_date": "20050114"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99)", "package_ndc": "65862-008-99", "marketing_start_date": "20050114"}], "brand_name": "Metformin Hydrochloride", "product_id": "65862-008_c535450c-12fd-478d-ad45-743c5badfc28", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "65862-008", "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": "ANDA077095", "marketing_category": "ANDA", "marketing_start_date": "20050114", "listing_expiration_date": "20261231"}