NDC 65219-205 - Temsirolimus

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
65219-205
Package NDCs from labels
65219-205-05
Manufacturer
Fresenius Kabi USA, LLC | Gland Pharma Limited
Effective date
2020-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temsirolimus - Fresenius Kabi USA, LLC | Gland Pharma LimitedFresenius Kabi USA, LLC | Gland Pharma Limited2020-03-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-205-05Temsirolimus1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1 mL25 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-205TEMSIROLIMUS KIT [FRESENIUS KABI USA, LLC]2Unmatched20201120_1c207bed-10e3-46f0-ad2c-69d5e5c97736.zip