tofacitinib 5 MG Oral Tablet

RxCUI: 1357541
RxNorm name: tofacitinib 5 MG Oral Tablet
Display name: Tofacitinib (Oral Pill)
Full name: tofacitinib 5 MG Oral Tablet
Term type: SCD
Status: Active
Strength: 5 mg
Dose form: Tab
Route: Oral Pill
Updated: 2026-07-24 06:51:59

RxNorm Status History#

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

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, Value, Category table
Code type	Value	Category
PRESCRIBABLE	Y	ATTRIBUTES
RXNAV_STR	tofacitinib 5 MG Oral Tablet	NAMES
RxNorm Name	tofacitinib 5 MG Oral Tablet	NAMES
RxNorm Synonym	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	NAMES
TTY	SCD	ATTRIBUTES
SPL_SET_ID	21a89264-8047-40ac-8b10-fa6461072509	CODES
SPL_SET_ID	253635c8-1ea7-41ba-b216-dea5e3305c47	CODES
SPL_SET_ID	2726c2b0-c763-4635-ac6b-4334c3a5a8bc	CODES
SPL_SET_ID	50962b08-99dd-ae73-e063-6394a90ad1eb	CODES
SPL_SET_ID	7d4f5cfa-35a8-1458-a609-f6b417946abb	CODES
SPL_SET_ID	9b654f0d-7705-4880-9e9d-ad3a51e56b56	CODES
SPL_SET_ID	c963c610-52e5-43ab-aac6-3f7e5341b764	CODES
SPL_SET_ID	f4d0e580-74a8-496e-89a2-d74478c946bf	CODES
SPL_SET_ID	ffa6819b-23a4-478b-8fb7-cc90e8142fc5	CODES
RxCUI	1357541	CODES
MMSL_CODE	CD27988	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
70710-1243-6	70710-1243	tofacitinib tofacitinib	Zydus Pharmaceuticals USA Inc.	ANDA209829
70710-1243-8	70710-1243	tofacitinib tofacitinib	Zydus Pharmaceuticals USA Inc.	ANDA209829
70771-1821-6	70771-1821	tofacitinib tofacitinib	Zydus Lifesciences Limited	ANDA209829
70771-1821-8	70771-1821	tofacitinib tofacitinib	Zydus Lifesciences Limited	ANDA209829

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA209829	70710-1243	tofacitinib tofacitinib	ANDA	Zydus Pharmaceuticals USA Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 21 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
33342054109	rxnav_ndcs	yes
33342054143	rxnav_ndcs	yes
33342054154	rxnav_ndcs	yes
33342054166	rxnav_ndcs	yes
42571026805	rxnav_ndcs	yes
42571026813	rxnav_ndcs	yes
42571026830	rxnav_ndcs	yes
42571026860	rxnav_ndcs	yes
42571026876	rxnav_ndcs	yes
51991032906	rxnav_ndcs	yes
51991032977	rxnav_ndcs	yes
59651045960	rxnav_ndcs	yes
60505626305	rxnav_ndcs	yes
60505626306	rxnav_ndcs	yes
70069084101	rxnav_ndcs	yes
70710124306	rxnav_ndcs	yes
70710124308	rxnav_ndcs	yes
70771182106	rxnav_ndcs	yes
70771182108	rxnav_ndcs	yes
72205013928	rxnav_ndcs	yes
72205013960	rxnav_ndcs	yes

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tofacitinib	TOFACITINIB	Apotex Corp.	7d4f5cfa-35a8-1458-a609-f6b417946abb	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 60505626306 ndc11 (package): 60505626305
TOFACITINIB	TOFACITINIB	Micro Labs Limited	ffa6819b-23a4-478b-8fb7-cc90e8142fc5	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 42571026813 ndc11 (package): 42571026860 ndc11 (package): 42571026830 ndc11 (package): 42571026876 ndc11 (package): 42571026805 rxcui: 1357541
tofacitinib	TOFACITINIB	Zydus Pharmaceuticals USA Inc.	21a89264-8047-40ac-8b10-fa6461072509	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 70710-1243-8 ndc (package): 70710-1243-6 ndc (product): 70710-1243 ndc11 (package): 70710124306 ndc11 (package): 70710124308 rxcui: 1357541
Tofacitinib	TOFACITINIB	AvKARE	5751321a-c904-44ae-e063-6394a90a2654	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1357541
TOFACITINIB	TOFACITINIB	Aurobindo Pharma Limited	50962b08-99dd-ae73-e063-6394a90ad1eb	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 59651045960 rxcui: 1357541
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1357541
XELJANZ XR	TOFACITINIB	Pfizer Laboratories Div Pfizer Inc	cf74ba2f-afc5-4baa-8594-979c889a5831	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1357541
Tofacitinib	TOFACITINIB	Novadoz Pharmaceuticals LLC	253635c8-1ea7-41ba-b216-dea5e3305c47	2026-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 72205013960 ndc11 (package): 72205013928 rxcui: 1357541
TOFACITINIB	TOFACITINIB	Somerset Therapeutics, LLC	2726c2b0-c763-4635-ac6b-4334c3a5a8bc	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 70069084101 rxcui: 1357541
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	f4d0e580-74a8-496e-89a2-d74478c946bf	2026-05-29		Exact identifier ndc (package): 70771-1821-6 ndc (package): 70771-1821-8 ndc (product): 70771-1821 ndc11 (package): 70771182108 ndc11 (package): 70771182106 rxcui: 1357541
Tofacitinib	TOFACITINIB CITRATE	Breckenridge Pharmaceutical, Inc.	c963c610-52e5-43ab-aac6-3f7e5341b764	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc11 (package): 51991032906 ndc11 (package): 51991032977 rxcui: 1357541

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
cf74ba2f-afc5-4baa-8594-979c889a5831	tofacitinib 5 MG Oral Tablet	SCD	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
cf74ba2f-afc5-4baa-8594-979c889a5831	tofacitinib 5 MG Oral Tablet	PSN	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
cf74ba2f-afc5-4baa-8594-979c889a5831	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	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	tofacitinib 5 MG Oral Tablet	SCD	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
68e3d6b2-7838-4d2d-a417-09d919b43e13	tofacitinib 5 MG Oral Tablet	PSN	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
68e3d6b2-7838-4d2d-a417-09d919b43e13	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	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
21a89264-8047-40ac-8b10-fa6461072509	tofacitinib 5 MG Oral Tablet	SCD	6	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	20260505
21a89264-8047-40ac-8b10-fa6461072509	tofacitinib 5 MG Oral Tablet	PSN	6	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	20260505
21a89264-8047-40ac-8b10-fa6461072509	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	6	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	20260505
f4d0e580-74a8-496e-89a2-d74478c946bf	tofacitinib 5 MG Oral Tablet	PSN	4	TOFACITINIB tablets, for oral use	20260505
f4d0e580-74a8-496e-89a2-d74478c946bf	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet	SY	4	TOFACITINIB tablets, for oral use	20260505
f4d0e580-74a8-496e-89a2-d74478c946bf	tofacitinib 5 MG Oral Tablet	SCD	4	TOFACITINIB tablets, for oral use	20260505

DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
9b654f0d-7705-4880-9e9d-ad3a51e56b56	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Macleods Pharmaceuticals Limited	20260806
7d4f5cfa-35a8-1458-a609-f6b417946abb	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Apotex Corp.	20260804
ffa6819b-23a4-478b-8fb7-cc90e8142fc5	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Micro Labs Limited	20260731
21a89264-8047-40ac-8b10-fa6461072509	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	20260730
50962b08-99dd-ae73-e063-6394a90ad1eb	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	20260717
50962b08-99dd-ae73-e063-6394a90ad1eb	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	20260706
253635c8-1ea7-41ba-b216-dea5e3305c47	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	20260606
21a89264-8047-40ac-8b10-fa6461072509	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	20260605
50962b08-99dd-ae73-e063-6394a90ad1eb	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	20260604
ffa6819b-23a4-478b-8fb7-cc90e8142fc5	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Micro Labs Limited	20260604
9b654f0d-7705-4880-9e9d-ad3a51e56b56	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Macleods Pharmaceuticals Limited	20260603
2726c2b0-c763-4635-ac6b-4334c3a5a8bc	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Somerset Therapeutics, LLC \| Bluepharma - Industria Farmaceutica, S.a.	20260602
f4d0e580-74a8-496e-89a2-d74478c946bf	TOFACITINIB tablets, for oral use	Zydus Lifesciences Limited	20260529
7d4f5cfa-35a8-1458-a609-f6b417946abb	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Apotex Corp.	20260520
c963c610-52e5-43ab-aac6-3f7e5341b764	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Breckenridge Pharmaceutical, Inc. \| Towa Pharmaceutical Europe, S.L.	20260507
21a89264-8047-40ac-8b10-fa6461072509	These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	20260505
f4d0e580-74a8-496e-89a2-d74478c946bf	TOFACITINIB tablets, for oral use	Zydus Lifesciences Limited	20260505

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	PRESCRIBABLE	Y
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
ATTRIBUTES	TTY	SCD
CODES	ANDA	ANDA209633
CODES	ANDA	ANDA209738
CODES	ANDA	ANDA209829
CODES	ANDA	ANDA215356
CODES	ANDA	ANDA217299
CODES	ANDA	ANDA218096
CODES	ANDA	ANDA219530
CODES	ANDA	ANDA220137
CODES	MMSL_CODE	CD27988
CODES	RxCUI	1357541
CODES	SNOMEDCT	783122002
CODES	SPL_SET_ID	21a89264-8047-40ac-8b10-fa6461072509
CODES	SPL_SET_ID	253635c8-1ea7-41ba-b216-dea5e3305c47
CODES	SPL_SET_ID	2726c2b0-c763-4635-ac6b-4334c3a5a8bc
CODES	SPL_SET_ID	50962b08-99dd-ae73-e063-6394a90ad1eb
CODES	SPL_SET_ID	7d4f5cfa-35a8-1458-a609-f6b417946abb
CODES	SPL_SET_ID	9b654f0d-7705-4880-9e9d-ad3a51e56b56
CODES	SPL_SET_ID	c963c610-52e5-43ab-aac6-3f7e5341b764
CODES	SPL_SET_ID	f4d0e580-74a8-496e-89a2-d74478c946bf
CODES	SPL_SET_ID	ffa6819b-23a4-478b-8fb7-cc90e8142fc5
CODES	VUID	4031785
NAMES	Prescribable Synonym	tofacitinib 5 MG Oral Tablet
NAMES	RXNAV_STR	tofacitinib 5 MG Oral Tablet
NAMES	RxNorm Name	tofacitinib 5 MG Oral Tablet
NAMES	RxNorm Synonym	tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	US Edition of SNOMED_CT
SOURCES	Source	Veterans Health Administration National Drug File