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 1 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6446
Product ID 50090-6446_6fd1d19f-3d72-4c29-b97b-d5a11dbeeb0b
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 500906446
Hyphenated Format 50090-6446

Supplemental Identifiers

RxCUI
636676
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
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (50090-6446-0)
source: ndc

Packages (1)

50090-6446-0 56 TABLET, FILM COATED in 1 BOTTLE (50090-6446-0)

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": "6fd1d19f-3d72-4c29-b97b-d5a11dbeeb0b", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636676"], "spl_set_id": ["92bc4c24-6c4f-4acf-b747-e3ef0cab1297"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (50090-6446-0)", "package_ndc": "50090-6446-0", "marketing_start_date": "20230420"}], "brand_name": "VARENICLINE", "product_id": "50090-6446_6fd1d19f-3d72-4c29-b97b-d5a11dbeeb0b", "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": "50090-6446", "generic_name": "VARENICLINE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA201962", "marketing_category": "ANDA", "marketing_start_date": "20230126", "listing_expiration_date": "20261231"}