tofacitinib 5 MG Oral Tablet [Xeljanz]

RxCUI: 1357547
RxNorm name: tofacitinib 5 MG Oral Tablet [Xeljanz]
Display name: XELJANZ (Oral Pill)
Full name: tofacitinib 5 MG Oral Tablet [Xeljanz]
Term type: SBD
Status: Active
Strength: 5 mg
Dose form: Tab
Route: Oral Pill
Updated: 2026-07-24 06:52:07

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 122012
Active start: 122012
Multiple ingredient: NO
Branded: YES

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
tofacitinib citrate	5 MG / 1 EACH	tofacitinib	tofacitinib

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Tablet	317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
tofacitinib	1357536

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	Xeljanz 5 MG Oral Tablet	1	NAMES
RxNorm Name	tofacitinib 5 MG Oral Tablet [Xeljanz]	1	NAMES
RxNorm Synonym	2 linked values Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet Xeljanz 5 MG Oral Tablet	2	NAMES
TTY	SBD	1	ATTRIBUTES
SPL_SET_ID	2 linked values 68e3d6b2-7838-4d2d-a417-09d919b43e13 cf74ba2f-afc5-4baa-8594-979c889a5831	2	CODES
RxCUI	1357547	1	CODES
MMSL_CODE	BD27988	1	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
0069-1001-01	0069-1001	XELJANZ tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA203214
63539-012-02	63539-012	XELJANZ tofacitinib	U.S. Pharmaceuticals	NDA203214

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
NDA203214	0069-1001	XELJANZ tofacitinib	NDA	Pfizer 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
NDC11	Source	Active
00069100101	rxnav_ndcs	yes
63539001202	rxnav_ndcs	yes
00069100102	rxnav_historical
00069100103	rxnav_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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
cf74ba2f-afc5-4baa-8594-979c889a5831	Xeljanz 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [Xeljanz] [SBD] · Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY] · Xeljanz 5 MG Oral Tablet [SY]	4	53	These 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	20260312
68e3d6b2-7838-4d2d-a417-09d919b43e13	Xeljanz 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [Xeljanz] [SBD] · Xeljanz 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY] · Xeljanz 5 MG Oral Tablet [SY]	4	17	These 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	20260327

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20261006
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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	20260925
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20260713
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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	20260712
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20260327
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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	20260312
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20260312
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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	20260130
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20260130
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd \| Pharmacia & Upjohn Company LLC	20251031
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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 Inc	20251030
cf74ba2f-afc5-4baa-8594-979c889a5831	These 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	Pfizer 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 Inc	20250611
68e3d6b2-7838-4d2d-a417-09d919b43e13	These 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	U.S. Pharmaceuticals \| Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd	20250306
0d8faf40-370d-4b8c-a839-3e1ba22f88e7		National Council for Prescription Drug Programs	20130213

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	L04AF	Janus-associated kinase (JAK) inhibitors	ATC1-4		tofacitinib
FDASPL	N0000190858	Janus Kinase Inhibitor	EPC	has_epc	tofacitinib
FDASPL	N0000190857	Janus Kinase Inhibitors	MOA	has_moa	tofacitinib
MEDRT	D010880	Piperidines	CHEM	has_ingredient	tofacitinib
MEDRT	D011743	Pyrimidines	CHEM	has_ingredient	tofacitinib
MEDRT	D001172	Arthritis, Rheumatoid	DISEASE	may_treat	tofacitinib
MEDRT	N0000190857	Janus Kinase Inhibitors	MOA	has_moa	tofacitinib
MEDRT	N0000008656	Decreased Hematopoiesis	PE	has_pe	tofacitinib
MEDRT	N0000175550	Decreased Immunologic Activity	PE	has_pe	tofacitinib

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Xeljanz	rxnav_allrelated
DF	DF	Oral Tablet	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	tofacitinib	rxnav_allrelated
SBD	SBD	tofacitinib 5 MG Oral Tablet [Xeljanz]	rxnav_allrelated
SBDC	SBDC	tofacitinib 5 MG [Xeljanz]	rxnav_allrelated
SBDF	SBDF	tofacitinib Oral Tablet [Xeljanz]	rxnav_allrelated
SBDG	SBDG	Xeljanz Oral Product	rxnav_allrelated
SBDG	SBDG	Xeljanz Pill	rxnav_allrelated
SCD	SCD	tofacitinib 5 MG Oral Tablet	rxnav_allrelated
SCDC	SCDC	tofacitinib 5 MG	rxnav_allrelated
SCDF	SCDF	tofacitinib Oral Tablet	rxnav_allrelated
SCDG	SCDG	tofacitinib Oral Product	rxnav_allrelated
SCDG	SCDG	tofacitinib Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	5 MG
ATTRIBUTES	GENERAL_CARDINALITY	SINGLE
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	NDA	NDA203214
NAMES	Prescribable Synonym	Xeljanz 5 MG Oral Tablet
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon