FDA.reportPublic FDA data

CHANTIX

Product NDC
50090-0998
11-digit product format
500900998
Labeler code
50090
Product ID
50090-0998_f6aca4b9-a63b-4e98-ae99-e293291be46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0998-02023-01-30C16284748780-19d75b9d0-c691-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006
50090-0998-02021-02-23C16284748780-19d75b9d0-c691-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006
50090-0998-02020-01-31C16284748780-19d75b9d0-c691-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0998-0CHANTIX1 in 1 KITKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0998-0EA - Each50090-0998263c1f94-39b0-44a9-b198-fed7f2c75a8512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0998CHANTIX (VARENICLINE TARTRATE) KIT [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210402_875351eb-1c25-44ad-9a37-799919216044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCK875351eb-1c25-44ad-9a37-7999192160446
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK875351eb-1c25-44ad-9a37-7999192160446
637188CHANTIX 0.5 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
637190CHANTIX 1 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
795737Chantix Starting Month PackPSN875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN875351eb-1c25-44ad-9a37-7999192160446
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD875351eb-1c25-44ad-9a37-7999192160446
637190varenicline 1 MG Oral Tablet [Chantix]SBD875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG Oral TabletSCD875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG Oral TabletSCD875351eb-1c25-44ad-9a37-7999192160446
637188Chantix 0.5 MG Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
637190Chantix 1 MG Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
795737Chantix First Month of Therapy PackSY875351eb-1c25-44ad-9a37-7999192160446
795737Chantix Starting Month PAKSY875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
749289varenicline first month of therapy PackSY875351eb-1c25-44ad-9a37-7999192160446
749289varenicline starting month Pack, 53 Oral TabletsSY875351eb-1c25-44ad-9a37-7999192160446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0998-0500900998001 KIT in 1 KIT (50090-0998-0) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK1 kit2014-11-280000-00-00NoNoCurrent