varenicline

Generic: varenicline tartrate

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler ajanta pharma usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate .5 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-173
Product ID 27241-173_1c32f27d-6637-481f-9df9-9ef064fd86e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213019
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

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 27241173
Hyphenated Format 27241-173

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0327241187575 0327241174117 0327241173561 0327241174568 0327241174773
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 tartrate (source: ndc)
Application Number ANDA213019 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (27241-173-56)
source: ndc

Packages (1)

27241-173-56 56 TABLET, FILM COATED in 1 BOTTLE (27241-173-56)

Ingredients (1)

varenicline tartrate (.5 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": "1c32f27d-6637-481f-9df9-9ef064fd86e4", "openfda": {"upc": ["0327241187575", "0327241174117", "0327241173561", "0327241174568", "0327241174773"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["2f86bb7b-c6a6-4915-8ba1-17251540971c"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (27241-173-56)", "package_ndc": "27241-173-56", "marketing_start_date": "20240131"}], "brand_name": "Varenicline", "product_id": "27241-173_1c32f27d-6637-481f-9df9-9ef064fd86e4", "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": "27241-173", "generic_name": "Varenicline tartrate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA213019", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}