FDA.reportPublic FDA data

XELJANZ

Product NDC
63539-016
11-digit product format
635390016
Labeler code
63539
Product ID
63539-016_184c6caf-b874-4b42-9a0d-30219f3fd2ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofacitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA203214
Marketing category
NDA
Marketing start
2018-07-02
Substance
TOFACITINIB CITRATE
Active strength
10 mg/1
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO1FF4DIV0D
Rxcui1357541, 1357547, 1741046, 1741049, 2048566, 2048568, 2273113, 2273115, 2478433, 2478437

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6Product name420250623
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63539-016-022021-08-14C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
63539-016-022021-08-14C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
63539-016-022021-08-14C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012
63539-016-022021-08-14C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
63539-016-022021-07-23C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
63539-016-022021-07-23C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012
63539-016-022021-07-23C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use XELJANZ ® (tofacitinib) Oral Solution Initial U.S. Approval: 2012
63539-016-022021-07-23C16284748780-1c7ccaba7-12bd-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-016-02XELJANZ60 in 1 BOTTLETABLET, FILM COATED6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63539-016-02EA - Each63539-0167a4fb4f3-3e8f-4eff-88b5-598978741ca612026-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOFACITINIB CITRATEACTIVE INGREDIENTO1FF4DIV0DXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TOFACITINIBACTIVE MOIETY87LA6FU830XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673XELJANZ (TOFACITINIB CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-016XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, EXTENDED RELEASE [U.S. PHARMACEUTICALS]13Current NDC, Legacy NDC, 1 package rows20250306_68e3d6b2-7838-4d2d-a417-09d919b43e13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2478433tofacitinib 1 MG/mL Oral SolutionPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048566tofacitinib 10 MG Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
2273113tofacitinib 22 MG 24HR Extended Release Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357541tofacitinib 5 MG Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
2478437Xeljanz 1 MG/mL Oral SolutionPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048568Xeljanz 10 MG Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357547Xeljanz 5 MG Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741049Xeljanz XR 11 MG 24HR Extended Release Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
2273115Xeljanz XR 22 MG 24HR Extended Release Oral TabletPSN68e3d6b2-7838-4d2d-a417-09d919b43e1317
174104924 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]SBD68e3d6b2-7838-4d2d-a417-09d919b43e1317
227311524 HR tofacitinib 22 MG Extended Release Oral Tablet [Xeljanz]SBD68e3d6b2-7838-4d2d-a417-09d919b43e1317
2478437tofacitinib 1 MG/ML Oral Solution [Xeljanz]SBD68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048568tofacitinib 10 MG Oral Tablet [Xeljanz]SBD68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357547tofacitinib 5 MG Oral Tablet [Xeljanz]SBD68e3d6b2-7838-4d2d-a417-09d919b43e1317
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCD68e3d6b2-7838-4d2d-a417-09d919b43e1317
227311324 HR tofacitinib 22 MG Extended Release Oral TabletSCD68e3d6b2-7838-4d2d-a417-09d919b43e1317
2478433tofacitinib 1 MG/ML Oral SolutionSCD68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048566tofacitinib 10 MG Oral TabletSCD68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357541tofacitinib 5 MG Oral TabletSCD68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048566tofacitinib 10 MG (as tofacitinib citrate 16 MG) Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357541tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
2478437Xeljanz 1 MG/ML Oral SolutionSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048568Xeljanz 10 MG (as tofacitinib citrate 16 MG) Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
2048568Xeljanz 10 MG Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357547Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1357547Xeljanz 5 MG Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741049Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
1741049Xeljanz XR 11 MG 24 HR Extended Release Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317
2273115Xeljanz XR 22 MG (as tofacitinib citrate 35.54 MG) 24 HR Extended Release Oral TabletSY68e3d6b2-7838-4d2d-a417-09d919b43e1317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63539-016-026353900160260 TABLET, FILM COATED in 1 BOTTLE (63539-016-02) 2018-07-020000-00-00NoNoCurrent