FDA.reportPublic FDA data

X

Manufacturer
AX Pharmaceutical Corp
Effective date
2016-08-25
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:19

Label at a glance#

ProductX
Active ingredientTofacitinib
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6Product name420250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62157-257-01X10 g in 1 JARPOWDER101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-257X (TOFACITINIB) POWDER [AX PHARMACEUTICAL CORP]11 package rows20160826_ae92e9d8-8a2e-45bf-aa61-814660ee32bc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-25762157-257-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tofacitinib87LA6FU830ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TofacitinibTOFACITINIBNovadoz Pharmaceuticals LLC253635c8-1ea7-41ba-b216-dea5e3305c472026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBNovadoz Pharmaceuticals LLC327f6b60-1a5d-49e6-acff-18603d0ee9d02026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBEdenbridge Pharmaceuticals LLC.576722e5-6639-452d-a5c3-33a064f194812026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBGolden State Medical Supply, Inc.58f22c41-87d2-e745-e063-6394a90a962e2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.179ffbb2-bedc-40e6-b77b-33d4f78321722026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBMacleods Pharmaceuticals Limited9b654f0d-7705-4880-9e9d-ad3a51e56b562026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBApotex Corp.7d4f5cfa-35a8-1458-a609-f6b417946abb2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
tofacitinibTOFACITINIBZydus Pharmaceuticals USA Inc.21a89264-8047-40ac-8b10-fa64610725092026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBSun Pharmaceutical Industries, Inc.a764a133-b870-4514-bbee-24d43f8cb7fd2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBApotex Corp.dd62a2b8-300b-d92b-7b27-a30eaa68fdd32026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBAvKARE5751321a-c904-44ae-e063-6394a90a26542026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBAurobindo Pharma Limitede54b186f-e42a-4477-939c-8dd331045fbe2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBAurobindo Pharma Limited50962b08-99dd-ae73-e063-6394a90ad1eb2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBIPG Pharmaceuticals, Inccd1b61bf-de03-4198-89f6-f3952b79d2c22026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
XELJANZTOFACITINIBU.S. Pharmaceuticals68e3d6b2-7838-4d2d-a417-09d919b43e132026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
tofacitinib solutionTOFACITINIBHikma Pharmaceuticals USA Inc.d9cf18a9-e825-49ac-b080-68957c0e79ae2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBOrient Pharma Co., Ltd. Yunlin Plant5617a652-a78e-74b1-e063-6394a90a31c72026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBAvKARE5502f252-2b39-2cfd-e063-6394a90a8a482026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TofacitinibTOFACITINIBAjanta Pharma USA Inc.024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB
TOFACITINIBTOFACITINIBSomerset Therapeutics, LLC2726c2b0-c763-4635-ac6b-4334c3a5a8bc2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOFACITINIB

Reported adverse events (FAERS/openFDA)#

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