FDA.reportPublic FDA data

CHANTIX

Product NDC
0069-0468
11-digit product format
000690468
Labeler code
0069
Product ID
0069-0468_09cce88b-e4f0-48b7-ac05-54d97976b4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
Substance
VARENICLINE TARTRATE
Active strength
.5 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHANTIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 637188, 637190, 749289, 749788, 795735, 795737

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0468-56CHANTIX56 in 1 BOTTLETABLET, FILM COATED5649

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0468-56EA - Each0069-0468748011c6-6ede-427b-a7f6-28f8daace2bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSEINACTIVE INGREDIENT029TFK992NCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TRIACETININACTIVE INGREDIENTXHX3C3X673CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
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
varenicline tartrateACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
vareniclineACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
anhydrous dibasic calcium phosphateINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0468CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]44Current NDC, Legacy NDC, 1 package rows20250110_f0ff4f27-5185-4881-a749-c6b7a0ca5696.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]BPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188CHANTIX 0.5 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190CHANTIX 1 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix Continuing Month Pack 1 MG 56 CountPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix Starting Month PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline 1 MG Oral Tablet 56 Count PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188varenicline 0.5 MG Oral Tablet [Chantix]SBDf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190varenicline 1 MG Oral Tablet [Chantix]SBDf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG Oral TabletSCDf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG Oral TabletSCDf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188Chantix 0.5 MG Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190Chantix 1 MG Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix Continuing Months Of Therapy 1 MG PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix First Month of Therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix Starting Month PAKSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline 1 MG Oral Tablet 56 Count PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline continuing months of therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline first month of therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline starting month Pack, 53 Oral TabletsSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188CHANTIX 0.5 MG Oral TabletPSN9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG Oral TabletPSN9a0d0273-8099-420a-b4e1-097153a4aecb3
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG Oral TabletSCD9a0d0273-8099-420a-b4e1-097153a4aecb3
637188Chantix 0.5 MG Oral TabletSY9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY9a0d0273-8099-420a-b4e1-097153a4aecb3
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
637188CHANTIX 0.5 MG Oral TabletPSNf990eca6-fe6f-4423-a118-4b7b970995a11
637188CHANTIX 0.5 MG Oral TabletPSN1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG Oral TabletPSN1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG Oral TabletPSNf990eca6-fe6f-4423-a118-4b7b970995a11
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD1053cbe5-dc3d-4d95-93de-0022a22a6ed11
637188varenicline 0.5 MG Oral Tablet [Chantix]SBDf990eca6-fe6f-4423-a118-4b7b970995a11
636671varenicline 0.5 MG Oral TabletSCD1053cbe5-dc3d-4d95-93de-0022a22a6ed11
636671varenicline 0.5 MG Oral TabletSCDf990eca6-fe6f-4423-a118-4b7b970995a11
637188Chantix 0.5 MG Oral TabletSY1053cbe5-dc3d-4d95-93de-0022a22a6ed11
637188Chantix 0.5 MG Oral TabletSYf990eca6-fe6f-4423-a118-4b7b970995a11
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYf990eca6-fe6f-4423-a118-4b7b970995a11
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0468-560006904685656 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56) 2006-05-100000-00-00NoNoCurrent