Package 68012-003-16
Brand: glumetza
Generic: metformin hydrochloridePackage 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
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"}