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

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
33342-541-09	33342-541	Tofacitinib Tofacitinib	Macleods Pharmaceuticals Limited	ANDA219530
33342-541-43	33342-541	Tofacitinib Tofacitinib	Macleods Pharmaceuticals Limited	ANDA219530
33342-541-54	33342-541	Tofacitinib Tofacitinib	Macleods Pharmaceuticals Limited	ANDA219530
42571-268-05	42571-268	TOFACITINIB tofacitinib	Micro Labs Limited	ANDA209738
42571-268-30	42571-268	TOFACITINIB tofacitinib	Micro Labs Limited	ANDA209738
42571-268-60	42571-268	TOFACITINIB tofacitinib	Micro Labs Limited	ANDA209738
42571-268-76	42571-268	TOFACITINIB tofacitinib	Micro Labs Limited	ANDA209738
51991-329-06	51991-329	Tofacitinib Tofacitinib Citrate	Breckenridge Pharmaceutical, Inc.	ANDA209633
59651-459-60	59651-459	TOFACITINIB TOFACITINIB	Aurobindo Pharma Limited	ANDA215356
60505-6263-5	60505-6263	Tofacitinib tofacitinib	Apotex Corp.	ANDA218096
60505-6263-6	60505-6263	Tofacitinib tofacitinib	Apotex Corp.	ANDA218096
70069-841-01	70069-841	TOFACITINIB TOFACITINIB	Somerset Therapeutics, LLC	ANDA220137
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
72205-139-28	72205-139	Tofacitinib Tofacitinib	Novadoz Pharmaceuticals LLC	ANDA217299
72205-139-60	72205-139	Tofacitinib Tofacitinib	Novadoz Pharmaceuticals LLC	ANDA217299

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA219530	33342-541	Tofacitinib Tofacitinib	ANDA	Macleods Pharmaceuticals Limited
ANDA209738	42571-268	TOFACITINIB tofacitinib	ANDA	Micro Labs Limited
ANDA209633	51991-329	Tofacitinib Tofacitinib Citrate	ANDA	Breckenridge Pharmaceutical, Inc.
ANDA215356	59651-459	TOFACITINIB TOFACITINIB	ANDA	Aurobindo Pharma Limited
ANDA218096	60505-6263	Tofacitinib tofacitinib	ANDA	Apotex Corp.
ANDA220137	70069-841	TOFACITINIB TOFACITINIB	ANDA	Somerset Therapeutics, LLC
ANDA209829	70710-1243	tofacitinib tofacitinib	ANDA	Zydus Pharmaceuticals USA Inc.
ANDA217299	72205-139	Tofacitinib Tofacitinib	ANDA	Novadoz Pharmaceuticals LLC

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	Novadoz Pharmaceuticals LLC	253635c8-1ea7-41ba-b216-dea5e3305c47	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 72205-139-60 ndc (package): 72205-139-28 ndc (product): 72205-139 ndc11 (package): 72205013960 ndc11 (package): 72205013928 rxcui: 1357541
Tofacitinib	TOFACITINIB	Golden State Medical Supply, Inc.	58f22c41-87d2-e745-e063-6394a90a962e	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1357541
Tofacitinib	TOFACITINIB	Macleods Pharmaceuticals Limited	9b654f0d-7705-4880-9e9d-ad3a51e56b56	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 33342-541-09 ndc (package): 33342-541-43 ndc (package): 33342-541-54 ndc (product): 33342-541 ndc11 (package): 33342054109 ndc11 (package): 33342054154 ndc11 (package): 33342054143 ndc11 (package): 33342054166 rxcui: 1357541
Tofacitinib	TOFACITINIB	Apotex Corp.	7d4f5cfa-35a8-1458-a609-f6b417946abb	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 60505-6263-6 ndc (package): 60505-6263-5 ndc (product): 60505-6263 ndc11 (package): 60505626306 ndc11 (package): 60505626305 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 ndc (package): 59651-459-60 ndc (product): 59651-459 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
TOFACITINIB	TOFACITINIB	Somerset Therapeutics, LLC	2726c2b0-c763-4635-ac6b-4334c3a5a8bc	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 70069-841-01 ndc (product): 70069-841 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	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 51991-329-06 ndc (product): 51991-329 ndc11 (package): 51991032906 ndc11 (package): 51991032977 rxcui: 1357541

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
cf74ba2f-afc5-4baa-8594-979c889a5831	tofacitinib 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]	3	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 [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]	3	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 [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]	3	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] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]	3	4	TOFACITINIB tablets, for oral use	20260505

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
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	20261005
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	20260925
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	20260918
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	20260901
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	20260813
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.	20260514
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	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
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	SNOMEDCT	783122002
CODES	VUID	4031785
NAMES	Prescribable Synonym	tofacitinib 5 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