FDA.reportPublic FDA data

NDC 0008-1279 - Torisel

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
0008-1279
Package NDCs from labels
0008-1279-01
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth Lederle SRL
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ToriselWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth Lederle SRL2025-12-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-1279-01Torisel25 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE25 mL25 mg in 1mL39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-1279TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]38Unmatched20250323_95b7dc92-2180-42f1-8699-3c28f609e674.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMSIROLIMUSACTIVE INGREDIENT624KN6GM2TTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TEMSIROLIMUSACTIVE MOIETY624KN6GM2TTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
ALCOHOLINACTIVE INGREDIENT3K9958V90MTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26