varenicline tartrate

Generic: varenicline tartrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline tartrate
Generic Name varenicline tartrate
Labeler lupin pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-125
Product ID 70748-125_3647a217-0da1-4778-adea-08d19a9c446f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211862
Listing Expiration 2026-12-31
Marketing Start 2024-03-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748125
Hyphenated Format 70748-125

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0370748128497 0370748127490
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 tartrate (source: ndc)
Generic Name varenicline tartrate (source: ndc)
Application Number ANDA211862 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (70748-125-13) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

70748-125-13 1 BLISTER PACK in 1 CARTON (70748-125-13) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VARENICLINE TARTRATE, VARENICLINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "3647a217-0da1-4778-adea-08d19a9c446f", "openfda": {"upc": ["0370748128497", "0370748127490"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["bf20c4cc-1731-4873-8de1-b93d17591e9f"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70748-125-13)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "70748-125-13", "marketing_start_date": "20240320"}], "brand_name": "VARENICLINE TARTRATE", "product_id": "70748-125_3647a217-0da1-4778-adea-08d19a9c446f", "dosage_form": "KIT", "product_ndc": "70748-125", "generic_name": "VARENICLINE TARTRATE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE TARTRATE", "application_number": "ANDA211862", "marketing_category": "ANDA", "marketing_start_date": "20240320", "listing_expiration_date": "20261231"}