FDA.reportPublic FDA data

CHANTIX

Product NDC
50090-4482
11-digit product format
500904482
Labeler code
50090
Product ID
50090-4482_0ca1f9ca-7518-4ba3-84a8-48a65c635963
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
2020-12-31
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
50090-4482-02023-01-30C16284748780-1f386c649-cb6f-0266-e053-dadaa90a7c1aThese 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
50090-4482-0CHANTIX1 in 1 CARTONTABLET, FILM COATED12
50090-4482-0CHANTIX56 in 1 BLISTER PACKTABLET, FILM COATED562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4482CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20191228_47c47343-e9b1-4892-b839-84d2919862ed.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]BPCK47c47343-e9b1-4892-b839-84d2919862ed2
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK47c47343-e9b1-4892-b839-84d2919862ed2
637190CHANTIX 1 MG Oral TabletPSN47c47343-e9b1-4892-b839-84d2919862ed2
795735Chantix Continuing Month Pack 1 MG 56 CountPSN47c47343-e9b1-4892-b839-84d2919862ed2
636676varenicline 1 MG Oral TabletPSN47c47343-e9b1-4892-b839-84d2919862ed2
749788varenicline 1 MG Oral Tablet 56 Count PackPSN47c47343-e9b1-4892-b839-84d2919862ed2
637190varenicline 1 MG Oral Tablet [Chantix]SBD47c47343-e9b1-4892-b839-84d2919862ed2
636676varenicline 1 MG Oral TabletSCD47c47343-e9b1-4892-b839-84d2919862ed2
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY47c47343-e9b1-4892-b839-84d2919862ed2
637190Chantix 1 MG Oral TabletSY47c47343-e9b1-4892-b839-84d2919862ed2
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSY47c47343-e9b1-4892-b839-84d2919862ed2
795735Chantix Continuing Months Of Therapy 1 MG PackSY47c47343-e9b1-4892-b839-84d2919862ed2
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY47c47343-e9b1-4892-b839-84d2919862ed2
749788varenicline 1 MG Oral Tablet 56 Count PackSY47c47343-e9b1-4892-b839-84d2919862ed2
749788varenicline continuing months of therapy PackSY47c47343-e9b1-4892-b839-84d2919862ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4482-0500904482001 BLISTER PACK in 1 CARTON (50090-4482-0) > 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-08-280000-00-00NoNoCurrent