varenicline

Generic: varenicline

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

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
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 50090-6447
Product ID 50090-6447_6cc32177-9e49-494f-b049-d115c0840056
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201962
Listing Expiration 2026-12-31
Marketing Start 2023-01-26

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 500906447
Hyphenated Format 50090-6447

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 (source: ndc)
Application Number ANDA201962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (50090-6447-0)
source: ndc

Packages (1)

50090-6447-0 56 TABLET, FILM COATED in 1 BOTTLE (50090-6447-0)

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": "6cc32177-9e49-494f-b049-d115c0840056", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671"], "spl_set_id": ["99414eca-c601-431c-8e84-2066b2e8221c"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (50090-6447-0)", "package_ndc": "50090-6447-0", "marketing_start_date": "20230420"}], "brand_name": "VARENICLINE", "product_id": "50090-6447_6cc32177-9e49-494f-b049-d115c0840056", "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": "50090-6447", "generic_name": "VARENICLINE", "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": "ANDA201962", "marketing_category": "ANDA", "marketing_start_date": "20230126", "listing_expiration_date": "20261231"}