varenicline

Generic: varenicline

Labeler: umedica laboratories usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler umedica laboratories usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Umedica Laboratories USA Inc.

Identifiers & Regulatory

Product NDC 60290-078
Product ID 60290-078_48e02d69-578d-6c15-e063-6394a90ade7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218985
Listing Expiration 2027-12-31
Marketing Start 2026-01-09

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 60290078
Hyphenated Format 60290-078

Supplemental Identifiers

RxCUI
636671 636676
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 (source: ndc)
Generic Name varenicline (source: ndc)
Application Number ANDA218985 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET in 1 BOTTLE (60290-078-01)
  • 60 BLISTER PACK in 1 CARTON (60290-078-02) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

60290-078-01 56 TABLET in 1 BOTTLE (60290-078-01) 60290-078-02 60 BLISTER PACK in 1 CARTON (60290-078-02) / 1 TABLET in 1 BLISTER PACK

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": "48e02d69-578d-6c15-e063-6394a90ade7c", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676"], "spl_set_id": ["f2e57493-d099-4055-8e92-67611c8d20f4"], "manufacturer_name": ["Umedica Laboratories USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET in 1 BOTTLE (60290-078-01)", "package_ndc": "60290-078-01", "marketing_start_date": "20260109"}, {"sample": false, "description": "60 BLISTER PACK in 1 CARTON (60290-078-02)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "60290-078-02", "marketing_start_date": "20260109"}], "brand_name": "VARENICLINE", "product_id": "60290-078_48e02d69-578d-6c15-e063-6394a90ade7c", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]", "Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "60290-078", "generic_name": "VARENICLINE", "labeler_name": "Umedica Laboratories USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA218985", "marketing_category": "ANDA", "marketing_start_date": "20260109", "listing_expiration_date": "20271231"}