FDA.reportPublic FDA data

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
IngredientStrengthBaseBasis of strength
tofacitinib citrate5 MG / 1 EACHtofacitinibtofacitinib

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
tofacitinib1357536

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRtofacitinib 5 MG Oral Tablet1NAMES
RxNorm Nametofacitinib 5 MG Oral Tablet1NAMES
RxNorm Synonymtofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
9 linked values
9CODES
RxCUI13575411CODES
MMSL_CODECD279881CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
70710-1243-670710-1243tofacitinib tofacitinibZydus Pharmaceuticals USA Inc.ANDA209829
70710-1243-870710-1243tofacitinib tofacitinibZydus Pharmaceuticals USA Inc.ANDA209829
70771-1821-670771-1821tofacitinib tofacitinibZydus Lifesciences LimitedANDA209829
70771-1821-870771-1821tofacitinib tofacitinibZydus Lifesciences LimitedANDA209829

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20982970710-1243tofacitinib tofacitinibANDAZydus 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
NDC11SourceActive
33342054109rxnav_ndcsyes
33342054143rxnav_ndcsyes
33342054154rxnav_ndcsyes
33342054166rxnav_ndcsyes
42571026805rxnav_ndcsyes
42571026813rxnav_ndcsyes
42571026830rxnav_ndcsyes
42571026860rxnav_ndcsyes
42571026876rxnav_ndcsyes
51991032906rxnav_ndcsyes
51991032977rxnav_ndcsyes
59651045960rxnav_ndcsyes
60505626305rxnav_ndcsyes
60505626306rxnav_ndcsyes
70069084101rxnav_ndcsyes
70710124306rxnav_ndcsyes
70710124308rxnav_ndcsyes
70771182106rxnav_ndcsyes
70771182108rxnav_ndcsyes
72205013928rxnav_ndcsyes
72205013960rxnav_ndcsyes

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBGolden State Medical Supply, Inc.58f22c41-87d2-e745-e063-6394a90a962e2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1357541
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 72205013960
ndc11 (package): 72205013928
rxcui: 1357541
TofacitinibTOFACITINIBMacleods Pharmaceuticals Limited9b654f0d-7705-4880-9e9d-ad3a51e56b562026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 33342054109
ndc11 (package): 33342054154
ndc11 (package): 33342054143
ndc11 (package): 33342054166
rxcui: 1357541
TofacitinibTOFACITINIBApotex Corp.7d4f5cfa-35a8-1458-a609-f6b417946abb2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 60505626306
ndc11 (package): 60505626305
rxcui: 1357541
TOFACITINIBTOFACITINIBMicro Labs Limitedffa6819b-23a4-478b-8fb7-cc90e8142fc52026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 42571026813
ndc11 (package): 42571026860
ndc11 (package): 42571026830
ndc11 (package): 42571026876
ndc11 (package): 42571026805
rxcui: 1357541
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.21a89264-8047-40ac-8b10-fa64610725092026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70710-1243-8
ndc (package): 70710-1243-6
ndc (product): 70710-1243
ndc11 (package): 70710124306
ndc11 (package): 70710124308
rxcui: 1357541
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1357541
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 59651045960
rxcui: 1357541
XELJANZTOFACITINIBU.S. Pharmaceuticals68e3d6b2-7838-4d2d-a417-09d919b43e132026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1357541
XELJANZ XRTOFACITINIBPfizer Laboratories Div Pfizer Inccf74ba2f-afc5-4baa-8594-979c889a58312026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1357541
TOFACITINIBTOFACITINIBSomerset Therapeutics, LLC2726c2b0-c763-4635-ac6b-4334c3a5a8bc2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 70069084101
rxcui: 1357541
tofacitinibTOFACITINIBZydus Lifesciences Limitedf4d0e580-74a8-496e-89a2-d74478c946bf2026-05-29Exact identifier
ndc (package): 70771-1821-6
ndc (package): 70771-1821-8
ndc (product): 70771-1821
ndc11 (package): 70771182108
ndc11 (package): 70771182106
rxcui: 1357541
TofacitinibTOFACITINIB CITRATEBreckenridge Pharmaceutical, Inc.c963c610-52e5-43ab-aac6-3f7e5341b7642026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 51991032906
ndc11 (package): 51991032977
rxcui: 1357541

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 IDRxNorm mappingsTermsSPL versionLabelEffective
cf74ba2f-afc5-4baa-8594-979c889a5831tofacitinib 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]353These 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-a417-09d919b43e13tofacitinib 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]317These 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
21a89264-8047-40ac-8b10-fa6461072509tofacitinib 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]36These 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: 201220260505
f4d0e580-74a8-496e-89a2-d74478c946bftofacitinib 5 MG Oral Tablet [PSN] · tofacitinib 5 MG Oral Tablet [SCD] · tofacitinib 5 MG (as tofacitinib citrate 8 MG) Oral Tablet [SY]34TOFACITINIB tablets, for oral use20260505

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
253635c8-1ea7-41ba-b216-dea5e3305c47These 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: 2012Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED20260901
253635c8-1ea7-41ba-b216-dea5e3305c47These 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: 2012Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED20260813
9b654f0d-7705-4880-9e9d-ad3a51e56b56These 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: 2012Macleods Pharmaceuticals Limited20260806
7d4f5cfa-35a8-1458-a609-f6b417946abbThese 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: 2012Apotex Corp.20260804
ffa6819b-23a4-478b-8fb7-cc90e8142fc5These 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: 2012Micro Labs Limited20260731
21a89264-8047-40ac-8b10-fa6461072509These 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: 2012Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited20260730
50962b08-99dd-ae73-e063-6394a90ad1ebThese 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: 2012Aurobindo Pharma Limited | APL HEALTHCARE LIMITED20260717
50962b08-99dd-ae73-e063-6394a90ad1ebThese 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: 2012Aurobindo Pharma Limited | APL HEALTHCARE LIMITED20260706
253635c8-1ea7-41ba-b216-dea5e3305c47These 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: 2012Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED20260606
21a89264-8047-40ac-8b10-fa6461072509These 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: 2012Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited20260605
50962b08-99dd-ae73-e063-6394a90ad1ebThese 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: 2012Aurobindo Pharma Limited | APL HEALTHCARE LIMITED20260604
ffa6819b-23a4-478b-8fb7-cc90e8142fc5These 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: 2012Micro Labs Limited20260604
9b654f0d-7705-4880-9e9d-ad3a51e56b56These 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: 2012Macleods Pharmaceuticals Limited20260603
2726c2b0-c763-4635-ac6b-4334c3a5a8bcThese 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: 2012Somerset Therapeutics, LLC | Bluepharma - Industria Farmaceutica, S.a.20260602
f4d0e580-74a8-496e-89a2-d74478c946bfTOFACITINIB tablets, for oral useZydus Lifesciences Limited20260529
7d4f5cfa-35a8-1458-a609-f6b417946abbThese 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: 2012Apotex Corp.20260520
c963c610-52e5-43ab-aac6-3f7e5341b764These 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: 2012Breckenridge Pharmaceutical, Inc. | Towa Pharmaceutical Europe, S.L.20260514
c963c610-52e5-43ab-aac6-3f7e5341b764These 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: 2012Breckenridge Pharmaceutical, Inc. | Towa Pharmaceutical Europe, S.L.20260507
21a89264-8047-40ac-8b10-fa6461072509These 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: 2012Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited20260505
f4d0e580-74a8-496e-89a2-d74478c946bfTOFACITINIB tablets, for oral useZydus Lifesciences Limited20260505

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_STRENGTH5 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA209633
CODESANDAANDA209738
CODESANDAANDA209829
CODESANDAANDA215356
CODESANDAANDA217299
CODESANDAANDA218096
CODESANDAANDA219530
CODESANDAANDA220137
CODESSNOMEDCT783122002
CODESVUID4031785
NAMESPrescribable Synonymtofacitinib 5 MG Oral Tablet
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File