FDA.reportPublic FDA data

CHANTIX

Product NDC
50090-0995
11-digit product format
500900995
Labeler code
50090
Product ID
50090-0995_354fc6b8-5326-48b3-8ac8-37de6ac8fb2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
Marketing end
0000-00-00
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA]
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
50090-0995-02023-01-30C16284748780-19d75b9d0-8f3e-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
50090-0995-02021-02-23C16284748780-19d75b9d0-8f3e-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
50090-0995-02020-01-31C16284748780-19d75b9d0-8f3e-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
50090-0995-0CHANTIX1 in 1 KITTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0995-0EA - Each50090-0995331e6571-ee9a-4087-b792-23217329a9a812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0995CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Legacy NDC, 1 package rows20210224_b90b0fa2-2348-49a8-97e5-d715d6e1ad6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
637190CHANTIX 1 MG Oral TabletPSNb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
795735Chantix Continuing Month Pack 1 MG 56 CountPSNb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
636676varenicline 1 MG Oral TabletPSNb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
749788varenicline 1 MG Oral Tablet 56 Count PackPSNb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
637190varenicline 1 MG Oral Tablet [Chantix]SBDb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
636676varenicline 1 MG Oral TabletSCDb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
637190Chantix 1 MG Oral TabletSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
795735Chantix Continuing Months Of Therapy 1 MG PackSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
749788varenicline 1 MG Oral Tablet 56 Count PackSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10
749788varenicline continuing months of therapy PackSYb90b0fa2-2348-49a8-97e5-d715d6e1ad6c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0995-0500900995001 TABLET, FILM COATED in 1 KIT (50090-0995-0) 2014-11-280000-00-00NoNoCurrent