Package 69315-403-56

Brand: varenicline tartrate

Generic: varenicline tartrate
NDC Package

Package Facts

Identity

Package NDC 69315-403-56
Digits Only 6931540356
Product NDC 69315-403
Description

56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56)

Marketing

Marketing Status
Marketed Since 2023-10-01
Brand varenicline tartrate
Generic varenicline tartrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "cd15d74e-92d3-4bf0-8c76-a01f9190b172", "openfda": {"upc": ["0369315403563", "0369315402566"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["fdb36cfa-d20a-4fd9-b994-a5d16e4bb438"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56)", "package_ndc": "69315-403-56", "marketing_start_date": "20231001"}, {"sample": false, "description": "1 BLISTER PACK in 1 BOX (69315-403-58)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69315-403-58", "marketing_start_date": "20231001"}], "brand_name": "VARENICLINE TARTRATE", "product_id": "69315-403_cd15d74e-92d3-4bf0-8c76-a01f9190b172", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]", "Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "69315-403", "generic_name": "VARENICLINE TARTRATE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE TARTRATE", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/561"}], "application_number": "ANDA217151", "marketing_category": "ANDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}