varenicline

Generic: varenicline

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2219
Product ID 72162-2219_a2386f55-4425-4caf-9b74-af9f5a80c2f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201962
Listing Expiration 2026-12-31
Marketing Start 2023-01-30

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 721622219
Hyphenated Format 72162-2219

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 (72162-2219-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72162-2219-3)
source: ndc

Packages (2)

72162-2219-2 56 TABLET, FILM COATED in 1 BOTTLE (72162-2219-2) 72162-2219-3 30 TABLET, FILM COATED in 1 BOTTLE (72162-2219-3)

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": "a2386f55-4425-4caf-9b74-af9f5a80c2f9", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636676"], "spl_set_id": ["dc0d2c60-b197-4bbf-a3fd-78e0f5a21440"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (72162-2219-2)", "package_ndc": "72162-2219-2", "marketing_start_date": "20240105"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72162-2219-3)", "package_ndc": "72162-2219-3", "marketing_start_date": "20240105"}], "brand_name": "VARENICLINE", "product_id": "72162-2219_a2386f55-4425-4caf-9b74-af9f5a80c2f9", "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": "72162-2219", "generic_name": "VARENICLINE", "labeler_name": "Bryant Ranch Prepack", "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": "20230130", "listing_expiration_date": "20261231"}