Package 42571-459-82

Brand: varenicline tartrate

Generic: varenicline tartrate
NDC Package

Package Facts

Identity

Package NDC 42571-459-82
Digits Only 4257145982
Product NDC 42571-459
Description

56 TABLET, FILM COATED in 1 BOTTLE (42571-459-82)

Marketing

Marketing Status
Marketed Since 2025-12-01
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": "426f1bdc-211b-b246-e063-6394a90a8de3", "openfda": {"upc": ["0342571475840", "0342571460884", "0342571460822", "0342571459826"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["ee603a5d-9a3c-4dbd-ba89-faf253dc8c42"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (42571-459-82)", "package_ndc": "42571-459-82", "marketing_start_date": "20251201"}], "brand_name": "varenicline tartrate", "product_id": "42571-459_426f1bdc-211b-b246-e063-6394a90a8de3", "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": "42571-459", "generic_name": "varenicline tartrate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline tartrate", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA218302", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}