FDA.reportPublic FDA data

CHANTIX

Product NDC
69189-0492
11-digit product format
691890492
Labeler code
69189
Product ID
69189-0492_e019fbcd-8038-4b99-91fe-e94adec0650d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA021928
Marketing category
NDA
Marketing start
2016-01-22
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
E
Listing certified through
2018-12-31
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
69189-0492-12020-01-31C16284748780-19d75b9d0-d9b4-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
69189-0492-1CHANTIX1 in 1 DOSE PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-0492CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170413_1053cbe5-dc3d-4d95-93de-0022a22a6ed1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637188CHANTIX 0.5 MG Oral TabletPSN1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG Oral TabletPSN1053cbe5-dc3d-4d95-93de-0022a22a6ed11
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG Oral TabletSCD1053cbe5-dc3d-4d95-93de-0022a22a6ed11
637188Chantix 0.5 MG Oral TabletSY1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY1053cbe5-dc3d-4d95-93de-0022a22a6ed11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-0492-1691890492011 in 1 DOSE PACKHistorical