varenicline

Generic: varenicline tartrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler major pharmaceuticals
Dosage Form KIT
Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7415
Product ID 0904-7415_1297c291-da28-4a73-9c28-d5adee36d7b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214557
Listing Expiration 2026-12-31
Marketing Start 2023-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047415
Hyphenated Format 0904-7415

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 tartrate (source: ndc)
Application Number ANDA214557 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (0904-7415-16) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7415-16 1 KIT in 1 CARTON (0904-7415-16) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

varenicline, Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "1297c291-da28-4a73-9c28-d5adee36d7b7", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["1297c291-da28-4a73-9c28-d5adee36d7b7"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0904-7415-16)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7415-16", "marketing_start_date": "20231218"}], "brand_name": "Varenicline", "product_id": "0904-7415_1297c291-da28-4a73-9c28-d5adee36d7b7", "dosage_form": "KIT", "product_ndc": "0904-7415", "generic_name": "Varenicline tartrate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA214557", "marketing_category": "ANDA", "marketing_start_date": "20231218", "listing_expiration_date": "20261231"}