FDA.reportPublic FDA data

XELJANZ

Product NDC
63539-012
11-digit product format
635390012
Labeler code
63539
Product ID
63539-012_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
2012-11-08
Substance
TOFACITINIB CITRATE
Active strength
5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203214-001XELJANZTOFACITINIB CITRATEEQ 5MG BASETABLET / ORALABRLD2012-11-06
N203214-002XELJANZTOFACITINIB CITRATEEQ 10MG BASETABLET / ORALABRLD, RS2018-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N203214-001AB
N203214-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203214-001RE417832025-12-08Drug substance2012-11-30
N203214-001RE41783*PED2026-06-08Pediatric extension
N203214-002RE417832025-12-08Drug substance2018-06-28
N203214-002RE41783*PED2026-06-08Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203214-001M-142028-02-21
N203214-001PED2028-08-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N203214-001XELJANZEQ 5MG BASETABLET / ORALABRLD2012-11-06a50c72e98297…
2026-08-01 22:54:322026-06N203214-002XELJANZEQ 10MG BASETABLET / ORALABRLD, RS2018-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N203214-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N203214-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N203214-001RE417832025-12-08Drug substance2012-11-30a50c72e98297…
2026-08-01 22:54:322026-06N203214-001RE41783*PED2026-06-08Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N203214-002RE417832025-12-08Drug substance2018-06-28a50c72e98297…
2026-08-01 22:54:322026-06N203214-002RE41783*PED2026-06-08Pediatric extensiona50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N203214-001M-142028-02-21a50c72e98297…
2026-08-01 22:54:322026-06N203214-001PED2028-08-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XELJANZTOFACITINIBU.S. Pharmaceuticals68e3d6b2-7838-4d2d-a417-09d919b43e132026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203214
application number: NDA203214
ndc (product): 63539-012
XELJANZ XRTOFACITINIBPfizer Laboratories Div Pfizer Inccf74ba2f-afc5-4baa-8594-979c889a58312026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203214
application number: NDA203214

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFACITINIB CITRATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O1FF4DIV0DInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68e3d6b2-7838-4d2d-a417-09d919b43e13Available on FDA.report

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
63539-012-022021-08-14C16284748780-1c7ccaba7-12bd-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
63539-012-022021-08-14C16284748780-1c7ccaba7-12bd-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
63539-012-022021-08-14C16284748780-1c7ccaba7-12bd-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
63539-012-022021-08-14C16284748780-1c7ccaba7-12bd-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
63539-012-022021-08-14C16284748780-1c7ccaba7-12bd-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
63539-012-022021-07-23C16284748780-1c7ccaba7-12bd-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
63539-012-022021-07-23C16284748780-1c7ccaba7-12bd-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
63539-012-022021-07-23C16284748780-1c7ccaba7-12bd-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
63539-012-022021-07-23C16284748780-1c7ccaba7-12bd-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
63539-012-022021-07-23C16284748780-1c7ccaba7-12bd-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
63539-012-02XELJANZ60 in 1 BOTTLETABLET, FILM COATED6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63539-012-02EA - Each63539-012323c472a-978e-473f-81d8-d6b25d5b51f112026-01-08

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
63539-012XELJANZ (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
63539-012-026353900120260 TABLET, FILM COATED in 1 BOTTLE (63539-012-02) 2012-11-080000-00-00NoNoCurrent