Package 68012-003-16

Brand: glumetza

Generic: metformin hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68012-003-16
Digits Only 6801200316
Product NDC 68012-003
Description

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16)

Marketing

Marketing Status
Marketed Since 2008-06-17
Brand glumetza
Generic metformin hydrochloride
Sample Package No

Linked Drug Pages (1)

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": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16)", "package_ndc": "68012-003-16", "marketing_start_date": "20080617"}], "brand_name": "Glumetza", "product_id": "68012-003_41eb528d-e235-4563-833a-5cf36381d6db", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68012-003", "generic_name": "metformin hydrochloride", "labeler_name": "Santarus, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glumetza", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA021748", "marketing_category": "NDA", "marketing_start_date": "20080617", "listing_expiration_date": "20261231"}