varenicline tartrate

Generic: varenicline tartrate

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline tartrate
Generic Name varenicline tartrate
Labeler leading pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/561

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-403
Product ID 69315-403_cd15d74e-92d3-4bf0-8c76-a01f9190b172
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217151
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

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 69315403
Hyphenated Format 69315-403

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0369315403563 0369315402566
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 ANDA217151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/561
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56)
  • 1 BLISTER PACK in 1 BOX (69315-403-58) / 56 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

69315-403-56 56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56) 69315-403-58 1 BLISTER PACK in 1 BOX (69315-403-58) / 56 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

varenicline tartrate (1 mg/561)

Linked Drug Pages (1)

VARENICLINE TARTRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd15d74e-92d3-4bf0-8c76-a01f9190b172", "openfda": {"upc": ["0369315403563", "0369315402566"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["fdb36cfa-d20a-4fd9-b994-a5d16e4bb438"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56)", "package_ndc": "69315-403-56", "marketing_start_date": "20231001"}, {"sample": false, "description": "1 BLISTER PACK in 1 BOX (69315-403-58)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69315-403-58", "marketing_start_date": "20231001"}], "brand_name": "VARENICLINE TARTRATE", "product_id": "69315-403_cd15d74e-92d3-4bf0-8c76-a01f9190b172", "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": "69315-403", "generic_name": "VARENICLINE TARTRATE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE TARTRATE", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/561"}], "application_number": "ANDA217151", "marketing_category": "ANDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}