FDA.reportPublic FDA data

Chantix

Product NDC
21695-946
11-digit product format
216950946
Labeler code
21695
Product ID
21695-946_b1b95503-1c7a-44e8-b5e0-d50b61db99d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
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
2017-12-31
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
21695-946-562019-09-24C16284748780-1934fe258-4959-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-946-56Chantix56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-946-56EA - Each21695-9461272b1fd-bd49-457c-9fe0-99ac3520fbbd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
varenicline tartrateACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
vareniclineACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
anhydrous dibasic calcium phosphateINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-946CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110722_b1b95503-1c7a-44e8-b5e0-d50b61db99d5.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]BPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188CHANTIX 0.5 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190CHANTIX 1 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix Continuing Month Pack 1 MG 56 CountPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix Starting Month PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline 1 MG Oral Tablet 56 Count PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188varenicline 0.5 MG Oral Tablet [Chantix]SBDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190varenicline 1 MG Oral Tablet [Chantix]SBDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG Oral TabletSCDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG Oral TabletSCDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188Chantix 0.5 MG Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190Chantix 1 MG Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix Continuing Months Of Therapy 1 MG PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix First Month of Therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix Starting Month PAKSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline 1 MG Oral Tablet 56 Count PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline continuing months of therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline first month of therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline starting month Pack, 53 Oral TabletsSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-946-562169509465656 in 1 BOTTLEHistorical