Package 69315-410-01

Brand: metformin hydrochloride er

Generic: metformin hydrochloride
NDC Package

Package Facts

Identity

Package NDC 69315-410-01
Digits Only 6931541001
Product NDC 69315-410
Description

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)

Marketing

Marketing Status
Marketed Since 2025-05-01
Brand metformin hydrochloride er
Generic metformin hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3383dbe6-8796-a02d-e063-6294a90a4a5c", "openfda": {"upc": ["0369315410011"], "unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["3dca884d-ec44-496f-9eeb-31fd8fa3f574"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)", "package_ndc": "69315-410-01", "marketing_start_date": "20250501"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)", "package_ndc": "69315-410-05", "marketing_start_date": "20250501"}], "brand_name": "METFORMIN HYDROCHLORIDE ER", "product_id": "69315-410_3383dbe6-8796-a02d-e063-6294a90a4a5c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69315-410", "generic_name": "metformin hydrochloride", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "brand_name_suffix": "ER", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}