glumetza

Generic: metformin hydrochloride

Labeler: santarus, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glumetza
Generic Name metformin hydrochloride
Labeler santarus, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Santarus, Inc.

Identifiers & Regulatory

Product NDC 68012-004
Product ID 68012-004_41eb528d-e235-4563-833a-5cf36381d6db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021748
Listing Expiration 2026-12-31
Marketing Start 2018-03-20

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68012004
Hyphenated Format 68012-004

Supplemental Identifiers

RxCUI
861015 861018 1807888 1807915
UPC
0368012003168 0368012004509
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 glumetza (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number NDA021748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)
source: ndc

Packages (1)

68012-004-50 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Glumetza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41eb528d-e235-4563-833a-5cf36381d6db", "openfda": {"upc": ["0368012003168", "0368012004509"], "unii": ["786Z46389E"], "rxcui": ["861015", "861018", "1807888", "1807915"], "spl_set_id": ["fb832474-88d9-4e29-95cd-fbc446944cc4"], "manufacturer_name": ["Santarus, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)", "package_ndc": "68012-004-50", "marketing_start_date": "20180320"}], "brand_name": "Glumetza", "product_id": "68012-004_41eb528d-e235-4563-833a-5cf36381d6db", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68012-004", "generic_name": "metformin hydrochloride", "labeler_name": "Santarus, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glumetza", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "NDA021748", "marketing_category": "NDA", "marketing_start_date": "20180320", "listing_expiration_date": "20261231"}