varenicline

Generic: varenicline tartrate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler northstar rxllc
Dosage Form KIT
Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-478
Product ID 72603-478_2318a1aa-9c4c-5925-e063-6394a90a5222
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214571
Listing Expiration 2026-12-31
Marketing Start 2024-09-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603478
Hyphenated Format 72603-478

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0372603476019 0372603477016
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 ANDA214571 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (72603-478-01) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

72603-478-01 1 KIT in 1 CARTON (72603-478-01) * 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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "2318a1aa-9c4c-5925-e063-6394a90a5222", "openfda": {"upc": ["0372603476019", "0372603477016"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["9031aa0d-2f68-4b9d-903f-ac0e95cbf35f"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72603-478-01)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "72603-478-01", "marketing_start_date": "20240923"}], "brand_name": "Varenicline", "product_id": "72603-478_2318a1aa-9c4c-5925-e063-6394a90a5222", "dosage_form": "KIT", "product_ndc": "72603-478", "generic_name": "Varenicline tartrate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA214571", "marketing_category": "ANDA", "marketing_start_date": "20240923", "listing_expiration_date": "20261231"}