Package 10135-809-56

Brand: varenicline

Generic: varenicline tartrate
NDC Package

Package Facts

Identity

Package NDC 10135-809-56
Digits Only 1013580956
Product NDC 10135-809
Product ID 10135-809_3effcc80-3b6f-8853-e063-6394a90a258d
Description

56 TABLET, FILM COATED in 1 BOTTLE (10135-809-56)

Marketing

Marketing Status
Marketed Since 2025-01-01
Brand varenicline
Generic varenicline tartrate
Sample Package No

Linked Drug Pages (1)

Varenicline ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3effcc80-3b6f-8853-e063-6394a90a258d", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676"], "spl_set_id": ["29b6b4ca-aeef-1295-e063-6394a90a21b9"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (10135-809-56)", "package_ndc": "10135-809-56", "marketing_start_date": "20250101"}], "brand_name": "Varenicline", "product_id": "10135-809_3effcc80-3b6f-8853-e063-6394a90a258d", "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": "10135-809", "generic_name": "Varenicline tartrate", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA217283", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}