FDA.reportPublic FDA data

sorafenib Tosylate

Manufacturer
AX Pharmaceutical Corp
Effective date
2023-08-29
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:52

Label at a glance#

Productsorafenib Tosylate
Active ingredientSORAFENIB TOSYLATE
Label structure1 sections

Label contents#

Full prescribing information#

Sorafenib Tosylate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33680929-c1c0-4a67-aa2e-1f98b8efd580Product name120240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-215-01sorafenib Tosylate1000 g in 1 JARPOWDER10002
73377-215-02sorafenib Tosylate500 g in 1 JARPOWDER5002
73377-215-03sorafenib Tosylate350 g in 1 JARPOWDER3502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-215SORAFENIB TOSYLATE POWDER [AX PHARMACEUTICAL CORP]23 package rows20230830_207725a4-e108-4afd-8c98-9abbe087126e.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-21573377-215-01, 73377-215-02, 73377-215-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SORAFENIB TOSYLATE5T62Q3B36JACTIM

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sorafenib TosylateSORAFENIBMylan Pharmaceuticals Inc.b7919013-1511-44f0-a759-3fa78a9fa1782026-03-18Warnings, Adverse reactionsName fallback
brand name: Sorafenib Tosylate

Reported adverse events (FAERS/openFDA)#

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