FDA.reportPublic FDA data

XELJANZ

Product NDC
0069-1002
11-digit product format
000691002
Labeler code
0069
Product ID
0069-1002_39aa36a4-7b51-43af-9bf0-d812b3f9bd1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofacitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
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

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
XELJANZ XRTOFACITINIBPfizer Laboratories Div Pfizer Inccf74ba2f-afc5-4baa-8594-979c889a58312026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203214
application number: NDA203214
ndc (product): 0069-1002

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1357541Internal RxNorm lookup
1357547Internal RxNorm lookup
1741046Internal RxNorm lookup
1741049Internal RxNorm lookup
2048566Internal RxNorm lookup
2048568Internal RxNorm lookup
2273113Internal RxNorm lookup
2273115Internal RxNorm lookup
2478433Internal RxNorm lookup
2478437Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf74ba2f-afc5-4baa-8594-979c889a5831Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1002-01XELJANZ60 in 1 BOTTLETABLET, FILM COATED6053

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1002-01EA - Each0069-1002a24cf820-06d7-4e3d-a7ee-a1d88526cb5312018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOFACITINIB CITRATEACTIVE INGREDIENTO1FF4DIV0DXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TOFACITINIBACTIVE MOIETY87LA6FU830XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12
TRIACETININACTIVE INGREDIENTXHX3C3X673XELJANZ (TOFACITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1002XELJANZ (TOFACITINIB) TABLET, FILM COATED XELJANZ XR (TOFACITINIB) TABLET, FILM COATED, EXTENDED RELEASE XELJANZ (TOFACITINIB) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]49Current NDC, Legacy NDC, 1 package rows20241222_cf74ba2f-afc5-4baa-8594-979c889a5831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2478433tofacitinib 1 MG/mL Oral SolutionPSNcf74ba2f-afc5-4baa-8594-979c889a583153
2048566tofacitinib 10 MG Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
1741046tofacitinib 11 MG 24HR Extended Release Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
2273113tofacitinib 22 MG 24HR Extended Release Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
1357541tofacitinib 5 MG Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
2478437Xeljanz 1 MG/mL Oral SolutionPSNcf74ba2f-afc5-4baa-8594-979c889a583153
2048568Xeljanz 10 MG Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
1357547Xeljanz 5 MG Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
1741049Xeljanz XR 11 MG 24HR Extended Release Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
2273115Xeljanz XR 22 MG 24HR Extended Release Oral TabletPSNcf74ba2f-afc5-4baa-8594-979c889a583153
174104924 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]SBDcf74ba2f-afc5-4baa-8594-979c889a583153
227311524 HR tofacitinib 22 MG Extended Release Oral Tablet [Xeljanz]SBDcf74ba2f-afc5-4baa-8594-979c889a583153
2478437tofacitinib 1 MG/ML Oral Solution [Xeljanz]SBDcf74ba2f-afc5-4baa-8594-979c889a583153
2048568tofacitinib 10 MG Oral Tablet [Xeljanz]SBDcf74ba2f-afc5-4baa-8594-979c889a583153
1357547tofacitinib 5 MG Oral Tablet [Xeljanz]SBDcf74ba2f-afc5-4baa-8594-979c889a583153
174104624 HR tofacitinib 11 MG Extended Release Oral TabletSCDcf74ba2f-afc5-4baa-8594-979c889a583153
227311324 HR tofacitinib 22 MG Extended Release Oral TabletSCDcf74ba2f-afc5-4baa-8594-979c889a583153
2478433tofacitinib 1 MG/ML Oral SolutionSCDcf74ba2f-afc5-4baa-8594-979c889a583153
2048566tofacitinib 10 MG Oral TabletSCDcf74ba2f-afc5-4baa-8594-979c889a583153
1357541tofacitinib 5 MG Oral TabletSCDcf74ba2f-afc5-4baa-8594-979c889a583153
2048566tofacitinib 10 MG (as tofacitinib citrate 16 MG) Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1741046tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1741046tofacitinib 11 MG 24 HR Extended Release Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1357541tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
2478437Xeljanz 1 MG/ML Oral SolutionSYcf74ba2f-afc5-4baa-8594-979c889a583153
2048568Xeljanz 10 MG (as tofacitinib citrate 16 MG) Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
2048568Xeljanz 10 MG Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1357547Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1357547Xeljanz 5 MG Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1741049Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
1741049Xeljanz XR 11 MG 24 HR Extended Release Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153
2273115Xeljanz XR 22 MG (as tofacitinib citrate 35.54 MG) 24 HR Extended Release Oral TabletSYcf74ba2f-afc5-4baa-8594-979c889a583153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-1002-010006910020160 TABLET, FILM COATED in 1 BOTTLE (0069-1002-01) 2018-07-020000-00-00NoNoCurrent
0069-1002-0200069100202180 TABLET, FILM COATED in 1 BOTTLE (0069-1002-02) 2018-07-020000-00-00NoNoCurrent
0069-1002-030006910020328 TABLET, FILM COATED in 1 BOTTLE (0069-1002-03) 2018-07-020000-00-00NoNoCurrent