Package 0378-6001-91
Brand: metformin hydrochloride
Generic: metforminPackage Facts
Identity
Package NDC
0378-6001-91
Digits Only
0378600191
Product NDC
0378-6001
Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)
Marketing
Marketing Status
Brand
metformin hydrochloride
Generic
metformin
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "40fb3426-10f9-4c69-a43a-4a72d143b350", "openfda": {"upc": ["0303786002917", "0303786001910"], "unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["7e41818c-60e9-4bcf-9586-7bb8d33d5e89"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)", "package_ndc": "0378-6001-91", "marketing_start_date": "20160823"}], "brand_name": "Metformin Hydrochloride", "product_id": "0378-6001_40fb3426-10f9-4c69-a43a-4a72d143b350", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0378-6001", "generic_name": "metformin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA200690", "marketing_category": "ANDA", "marketing_start_date": "20160823", "listing_expiration_date": "20261231"}