varenicline

Generic: varenicline

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-418
Product ID 59651-418_0004a0bb-87c0-46f8-b36a-95c98107395d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214595
Listing Expiration 2026-12-31
Marketing Start 2025-05-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651418
Hyphenated Format 59651-418

Supplemental Identifiers

RxCUI
636671 636676 749289
UNII
82269ASB48

Packaging Origin

Original Packager
true

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 varenicline (source: ndc)
Generic Name varenicline (source: ndc)
Application Number ANDA214595 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-418-55) / 56 TABLET, FILM COATED in 1 BLISTER PACK
  • 56 TABLET, FILM COATED in 1 BOTTLE (59651-418-56)
source: ndc

Packages (2)

59651-418-55 1 BLISTER PACK in 1 CARTON (59651-418-55) / 56 TABLET, FILM COATED in 1 BLISTER PACK 59651-418-56 56 TABLET, FILM COATED in 1 BOTTLE (59651-418-56)

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0004a0bb-87c0-46f8-b36a-95c98107395d", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["0004a0bb-87c0-46f8-b36a-95c98107395d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-418-55)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59651-418-55", "marketing_start_date": "20250502"}, {"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (59651-418-56)", "package_ndc": "59651-418-56", "marketing_start_date": "20250502"}], "brand_name": "Varenicline", "product_id": "59651-418_0004a0bb-87c0-46f8-b36a-95c98107395d", "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": "59651-418", "generic_name": "Varenicline", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA214595", "marketing_category": "ANDA", "marketing_start_date": "20250502", "listing_expiration_date": "20261231"}