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 KIT
Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-187
Product ID 27241-187_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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241187
Hyphenated Format 27241-187

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: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (27241-187-57) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 11 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

27241-187-57 1 KIT in 1 CARTON (27241-187-57) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 11 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "1 KIT in 1 CARTON (27241-187-57)  *  42 TABLET, FILM COATED in 1 BLISTER PACK *  11 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "27241-187-57", "marketing_start_date": "20240131"}], "brand_name": "Varenicline", "product_id": "27241-187_1c32f27d-6637-481f-9df9-9ef064fd86e4", "dosage_form": "KIT", "product_ndc": "27241-187", "generic_name": "Varenicline tartrate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA213019", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}