FDA.reportPublic FDA data

NDC 71656-071-08 - Tofacitinib

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71656-071
Requested NDC
71656-071-08
Package NDCs from labels
71656-071-08
Manufacturer
Saptalis Pharmaceuticals, LLC.
Effective date
2026-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tofacitinib - Saptalis Pharmaceuticals, LLC.Saptalis Pharmaceuticals, LLC.2026-10-15HUMAN PRESCRIPTION DRUG LABEL

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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBNovadoz Pharmaceuticals LLC327f6b60-1a5d-49e6-acff-18603d0ee9d02026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TofacitinibTOFACITINIBEdenbridge Pharmaceuticals LLC.576722e5-6639-452d-a5c3-33a064f194812026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TofacitinibTOFACITINIBMacleods Pharmaceuticals Limited9b654f0d-7705-4880-9e9d-ad3a51e56b562026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIB CITRATETOFACITINIB CITRATERadha Pharmaceuticals, Inc.141ab3eb-982b-4242-89db-6ddce5be0c402026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIB CITRATETOFACITINIB CITRATEScieGen Pharmaceuticals, INC.11d08738-efa3-4474-8eda-812bc04adfbb2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBIPG Pharmaceuticals, Inccd1b61bf-de03-4198-89f6-f3952b79d2c22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
tofacitinib solutionTOFACITINIBHikma Pharmaceuticals USA Inc.d9cf18a9-e825-49ac-b080-68957c0e79ae2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: VCQ006KQ1E
TofacitinibTOFACITINIBAvKARE5502f252-2b39-2cfd-e063-6394a90a8a482026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
TOFACITINIBTOFACITINIBSomerset Therapeutics, LLC2726c2b0-c763-4635-ac6b-4334c3a5a8bc2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O1FF4DIV0D
tofacitinibTOFACITINIBZydus Lifesciences Limitedf4d0e580-74a8-496e-89a2-d74478c946bf2026-05-29Exact identifier
unii: O1FF4DIV0D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.