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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-477
Product ID 72603-477_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

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 72603477
Hyphenated Format 72603-477

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: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (72603-477-01)
source: ndc

Packages (1)

72603-477-01 56 TABLET, FILM COATED in 1 BOTTLE (72603-477-01)

Ingredients (1)

varenicline tartrate (1 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": "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": "56 TABLET, FILM COATED in 1 BOTTLE (72603-477-01)", "package_ndc": "72603-477-01", "marketing_start_date": "20240923"}], "brand_name": "Varenicline", "product_id": "72603-477_2318a1aa-9c4c-5925-e063-6394a90a5222", "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": "72603-477", "generic_name": "Varenicline tartrate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA214571", "marketing_category": "ANDA", "marketing_start_date": "20240923", "listing_expiration_date": "20261231"}