CHANTIX

Product NDC
68151-4953
11-digit product format
681514953
Labeler code
68151
Product ID
68151-4953_88048960-8979-4063-8bbf-6000b8cf3c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4953-5CHANTIX1 in 1 PACKAGETABLET, FILM COATED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4953CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140820_4aa4019c-737f-4906-bfd9-ca37a74e7c40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637188CHANTIX 0.5 MG Oral TabletPSN4aa4019c-737f-4906-bfd9-ca37a74e7c402
636671varenicline 0.5 MG Oral TabletPSN4aa4019c-737f-4906-bfd9-ca37a74e7c402
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD4aa4019c-737f-4906-bfd9-ca37a74e7c402
636671varenicline 0.5 MG Oral TabletSCD4aa4019c-737f-4906-bfd9-ca37a74e7c402
637188Chantix 0.5 MG Oral TabletSY4aa4019c-737f-4906-bfd9-ca37a74e7c402
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY4aa4019c-737f-4906-bfd9-ca37a74e7c402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4953-5681514953051 in 1 PACKAGEHistorical