X

Manufacturer: AX Pharmaceutical Corp
Effective date: 2017-02-22
Label type: BULK INGREDIENT
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:48:23

Label at a glance#

ProductX

Active ingredientTofacitinib Citrate

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10e4c2fb-ffa2-728d-14d9-1c6c2f2b27b6	Product name	4	20250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62157-383-01	X	25 g in 1 JAR	POWDER	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62157-383	X (TOFACITINIB CITRATE) POWDER [AX PHARMACEUTICAL CORP]	1	1 package rows	20170223_cb6b5f51-abb9-4c52-a221-7c27cee18ee7.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

X
Tofacitinib Citrate
TOFACITINIB
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62157-383	62157-383-01

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
Name	UNII	Kind
Tofacitinib Citrate	O1FF4DIV0D	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOFACITINIB CITRATE	TOFACITINIB CITRATE	Radha Pharmaceuticals, Inc.	141ab3eb-982b-4242-89db-6ddce5be0c40	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB CITRATE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	ScieGen Pharmaceuticals, INC.	11d08738-efa3-4474-8eda-812bc04adfbb	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB CITRATE
Tofacitinib	TOFACITINIB CITRATE	Breckenridge Pharmaceutical, Inc.	c963c610-52e5-43ab-aac6-3f7e5341b764	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB CITRATE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	Padagis US LLC	df24e90d-4b2c-4f9d-a1d6-fcb1ab00606f	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB CITRATE

Reported adverse events (FAERS/openFDA)#

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