chantix

Generic: varenicline tartrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name chantix
Generic Name varenicline tartrate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-899
Product ID 43353-899_45cfd34d-08ac-40a8-95b3-21d3fea687c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021928
Listing Expiration 2026-12-31
Marketing Start 2006-05-10

Pharmacologic Class

Classes
partial cholinergic nicotinic agonist [epc] partial cholinergic nicotinic agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353899
Hyphenated Format 43353-899

Supplemental Identifiers

RxCUI
636676 637190
UNII
82269ASB48

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chantix (source: ndc)
Generic Name varenicline tartrate (source: ndc)
Application Number NDA021928 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05)
source: ndc

Packages (1)

43353-899-05 4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05)

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

CHANTIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45cfd34d-08ac-40a8-95b3-21d3fea687c3", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636676", "637190"], "spl_set_id": ["b4403cea-6300-4d89-8fde-5149a80b08b9"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05)", "package_ndc": "43353-899-05", "marketing_start_date": "20140307"}], "brand_name": "CHANTIX", "product_id": "43353-899_45cfd34d-08ac-40a8-95b3-21d3fea687c3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "43353-899", "generic_name": "varenicline tartrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CHANTIX", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "NDA021928", "marketing_category": "NDA", "marketing_start_date": "20060510", "listing_expiration_date": "20261231"}