metformin hydrochloride

Generic: metformin hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-178
Product ID 65162-178_984302ad-793e-4f35-92da-e5e7f92154f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078596
Listing Expiration 2026-12-31
Marketing Start 2009-12-02

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162178
Hyphenated Format 65162-178

Supplemental Identifiers

RxCUI
860975 860981
UPC
0365162178104 0365162179101
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 ANDA078596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50)
  • 10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89)
source: ndc

Packages (6)

65162-178-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03) 65162-178-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09) 65162-178-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10) 65162-178-11 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11) 65162-178-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50) 65162-178-89 10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89)

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": "984302ad-793e-4f35-92da-e5e7f92154f6", "openfda": {"upc": ["0365162178104", "0365162179101"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["c01a79e0-f2b7-4d99-857e-bda7f24fe319"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03)", "package_ndc": "65162-178-03", "marketing_start_date": "20091202"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09)", "package_ndc": "65162-178-09", "marketing_start_date": "20091202"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10)", "package_ndc": "65162-178-10", "marketing_start_date": "20091202"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11)", "package_ndc": "65162-178-11", "marketing_start_date": "20091202"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50)", "package_ndc": "65162-178-50", "marketing_start_date": "20091202"}, {"sample": false, "description": "10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89)", "package_ndc": "65162-178-89", "marketing_start_date": "20091202"}], "brand_name": "Metformin Hydrochloride", "product_id": "65162-178_984302ad-793e-4f35-92da-e5e7f92154f6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "65162-178", "generic_name": "Metformin Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078596", "marketing_category": "ANDA", "marketing_start_date": "20091202", "listing_expiration_date": "20261231"}