metformin hydrochloride

Generic: metformin hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-338
Product ID 68180-338_2da9ae97-97e8-43fe-b92a-00f3f7c25673
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091664
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180338
Hyphenated Format 68180-338

Supplemental Identifiers

RxCUI
1807888 1807915
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 ANDA091664 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-338-01)
source: ndc

Packages (1)

68180-338-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-338-01)

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": "2da9ae97-97e8-43fe-b92a-00f3f7c25673", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["1200ea71-8a9e-4e49-bb77-7d9fe0d84ae7"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-338-01)", "package_ndc": "68180-338-01", "marketing_start_date": "20160201"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68180-338_2da9ae97-97e8-43fe-b92a-00f3f7c25673", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68180-338", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA091664", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}