FDA.reportPublic FDA data

tofacitinib 11 MG 24HR Extended Release Oral Tablet

RxCUI
1741046
RxNorm name
tofacitinib 11 MG 24HR Extended Release Oral Tablet
Display name
tofacitinib 11 MG 24HR Extended Release Oral Tablet
Full name
tofacitinib 11 MG 24HR Extended Release Oral Tablet
Term type
PSN
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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBApotex Corp.dd62a2b8-300b-d92b-7b27-a30eaa68fdd32026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIB CITRATETOFACITINIB CITRATERadha Pharmaceuticals, Inc.141ab3eb-982b-4242-89db-6ddce5be0c402026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIB CITRATETOFACITINIB CITRATEScieGen Pharmaceuticals, INC.11d08738-efa3-4474-8eda-812bc04adfbb2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
XELJANZTOFACITINIBU.S. Pharmaceuticals68e3d6b2-7838-4d2d-a417-09d919b43e132026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
XELJANZ XRTOFACITINIBPfizer Laboratories Div Pfizer Inccf74ba2f-afc5-4baa-8594-979c889a58312026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TofacitinibTOFACITINIBAvKARE5502f252-2b39-2cfd-e063-6394a90a8a482026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TofacitinibTOFACITINIBEdenbridge Pharmaceuticals LLC.576722e5-6639-452d-a5c3-33a064f194812026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
tofacitinibTOFACITINIBZydus Lifesciences Limitedac0b26d5-1352-42ff-b5ea-3eb02d8508a42026-05-12Exact identifier
rxcui: 1741046
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIBTOFACITINIBExelan pharmaceuticals,Ince68680e5-0328-4e66-b8bb-4af126221ec72026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
TOFACITINIB CITRATETOFACITINIB CITRATEPadagis US LLCdf24e90d-4b2c-4f9d-a1d6-fcb1ab00606f2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046
Tofacitinib XRTOFACITINIBBiocon Pharma Incf0160e3d-63ea-75fb-4b88-fe3d6a6ce0302026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1741046

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
cf74ba2f-afc5-4baa-8594-979c889a5831tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY53These 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 11 MG 24HR Extended Release Oral TabletPSN53These 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-8594-979c889a583124 HR tofacitinib 11 MG Extended Release Oral TabletSCD53These 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 11 MG 24 HR Extended Release Oral TabletSY53These 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 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY17These 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 11 MG 24 HR Extended Release Oral TabletSY17These 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-a417-09d919b43e1324 HR tofacitinib 11 MG Extended Release Oral TabletSCD17These 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 11 MG 24HR Extended Release Oral TabletPSN17These 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
e54b186f-e42a-4477-939c-8dd331045fbetofacitinib 11 MG 24 HR Extended Release Oral TabletSY7These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260312
e54b186f-e42a-4477-939c-8dd331045fbetofacitinib 11 MG 24HR Extended Release Oral TabletPSN7These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260312
e54b186f-e42a-4477-939c-8dd331045fbe24 HR tofacitinib 11 MG Extended Release Oral TabletSCD7These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260312
e54b186f-e42a-4477-939c-8dd331045fbetofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY7These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260312
179ffbb2-bedc-40e6-b77b-33d4f7832172tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY6These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260512
179ffbb2-bedc-40e6-b77b-33d4f7832172tofacitinib 11 MG 24 HR Extended Release Oral TabletSY6These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260512
179ffbb2-bedc-40e6-b77b-33d4f7832172tofacitinib 11 MG 24HR Extended Release Oral TabletPSN6These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260512
179ffbb2-bedc-40e6-b77b-33d4f783217224 HR tofacitinib 11 MG Extended Release Oral TabletSCD6These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 201220260512
ac0b26d5-1352-42ff-b5ea-3eb02d8508a4tofacitinib 11 MG 24HR Extended Release Oral TabletPSN5TOFACITINIB Extended-Release Tablets20260512
ac0b26d5-1352-42ff-b5ea-3eb02d8508a4tofacitinib 11 MG 24 HR Extended Release Oral TabletSY5TOFACITINIB Extended-Release Tablets20260512
ac0b26d5-1352-42ff-b5ea-3eb02d8508a424 HR tofacitinib 11 MG Extended Release Oral TabletSCD5TOFACITINIB Extended-Release Tablets20260512
ac0b26d5-1352-42ff-b5ea-3eb02d8508a4tofacitinib 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral TabletSY5TOFACITINIB Extended-Release Tablets20260512