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.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 63539-012-02 ndc (product): 63539-012 ndc11 (package): 63539001202 rxcui: 1357547

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
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
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