FDA.reportPublic FDA data

tofacitinib 1 MG/ML Oral Solution

RxCUI
2478433
RxNorm name
tofacitinib 1 MG/ML Oral Solution
Display name
tofacitinib 1 MG/ML Oral Solution
Full name
tofacitinib 1 MG/ML Oral Solution
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOFACITINIBTOFACITINIBSun Pharmaceutical Industries, Inc.a764a133-b870-4514-bbee-24d43f8cb7fd2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
TOFACITINIBTOFACITINIBIPG Pharmaceuticals, Inccd1b61bf-de03-4198-89f6-f3952b79d2c22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
XELJANZTOFACITINIBU.S. Pharmaceuticals68e3d6b2-7838-4d2d-a417-09d919b43e132026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
XELJANZ XRTOFACITINIBPfizer Laboratories Div Pfizer Inccf74ba2f-afc5-4baa-8594-979c889a58312026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
TOFACITINIBTOFACITINIBNovadoz Pharmaceuticals LLC327f6b60-1a5d-49e6-acff-18603d0ee9d02026-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433
tofacitinib solutionTOFACITINIBHikma Pharmaceuticals USA Inc.d9cf18a9-e825-49ac-b080-68957c0e79ae2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2478433

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
cf74ba2f-afc5-4baa-8594-979c889a5831tofacitinib 1 MG/mL Oral SolutionPSN53These 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: 201220260312
cf74ba2f-afc5-4baa-8594-979c889a5831tofacitinib 1 MG/ML Oral SolutionSCD53These 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: 201220260312
68e3d6b2-7838-4d2d-a417-09d919b43e13tofacitinib 1 MG/mL Oral SolutionPSN17These 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: 201220260327
68e3d6b2-7838-4d2d-a417-09d919b43e13tofacitinib 1 MG/ML Oral SolutionSCD17These 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: 201220260327