varenicline

Generic: varenicline tartrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate .5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7135
Product ID 50090-7135_cc56f26e-8b25-442c-a8b1-c3dfc7fee841
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214557
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

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 500907135
Hyphenated Format 50090-7135

Supplemental Identifiers

RxCUI
636671
UNII
82269ASB48

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: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (50090-7135-0)
source: ndc

Packages (1)

50090-7135-0 56 TABLET, FILM COATED in 1 BOTTLE (50090-7135-0)

Ingredients (1)

varenicline tartrate (.5 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": "cc56f26e-8b25-442c-a8b1-c3dfc7fee841", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671"], "spl_set_id": ["2d5dfa6e-e69d-414a-8ff2-44714debbbe2"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (50090-7135-0)", "package_ndc": "50090-7135-0", "marketing_start_date": "20240419"}], "brand_name": "varenicline", "product_id": "50090-7135_cc56f26e-8b25-442c-a8b1-c3dfc7fee841", "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": "50090-7135", "generic_name": "varenicline tartrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA214557", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}