24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]

RxCUI
1741049
RxNorm name
24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]
Display name
XELJANZ XR (Oral Pill)
Full name
24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]
Term type
SBD
Status
Active
Strength
11 mg
Dose form
24 HR XR Tab
Route
Oral Pill
Updated
2026-10-22 07:00:26

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042016
Active start
042016
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
tofacitinib citrate11 MG / 1 EACHtofacitinibtofacitinib

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
tofacitinib1357536

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0069-0501-300069-0501XELJANZ tofacitinibPfizer Laboratories Div Pfizer IncNDA208246
63539-501-3063539-501XELJANZ tofacitinibU.S. PharmaceuticalsNDA208246

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2082460069-0501XELJANZ tofacitinibNDAPfizer Laboratories Div Pfizer Inc

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00069050130rxnav_ndcsyes
63539050114rxnav_ndcsyes
63539050130rxnav_ndcsyes
00069050114rxnav_historical

UNII Substances#

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

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
cf74ba2f-afc5-4baa-8594-979c889a5831Xeljanz XR 11 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz] [SBD] · Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet [SY] · Xeljanz XR 11 MG 24 HR Extended Release Oral Tablet [SY]453These 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-a417-09d919b43e13Xeljanz XR 11 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz] [SBD] · Xeljanz XR 11 MG (as tofacitinib citrate 17.77 MG) 24 HR Extended Release Oral Tablet [SY] · Xeljanz XR 11 MG 24 HR Extended Release Oral Tablet [SY]417These 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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20261006
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd20260925
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20260713
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd20260712
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20260327
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd20260312
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20260312
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd20260130
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20260130
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC20251031
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | Pfizer Inc20251030
cf74ba2f-afc5-4baa-8594-979c889a5831These 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: 2012Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | Pfizer Inc20250611
68e3d6b2-7838-4d2d-a417-09d919b43e13These 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: 2012U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd20250306

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCL04AFJanus-associated kinase (JAK) inhibitorsATC1-4tofacitinib
FDASPLN0000190858Janus Kinase InhibitorEPChas_epctofacitinib
FDASPLN0000190857Janus Kinase InhibitorsMOAhas_moatofacitinib
MEDRTD010880PiperidinesCHEMhas_ingredienttofacitinib
MEDRTD011743PyrimidinesCHEMhas_ingredienttofacitinib
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treattofacitinib
MEDRTN0000190857Janus Kinase InhibitorsMOAhas_moatofacitinib
MEDRTN0000008656Decreased HematopoiesisPEhas_petofacitinib
MEDRTN0000175550Decreased Immunologic ActivityPEhas_petofacitinib

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH11 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA208246
NAMESPrescribable SynonymXeljanz XR 11 MG 24HR Extended Release Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon