FDA.reportPublic FDA data

NDC 16729-221 - 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
16729-221
Package NDCs from labels
16729-221-30
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2024-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temsirolimus - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2024-02-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-221-30Temsirolimus1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1 mL25 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-221TEMSIROLIMUS KIT [ACCORD HEALTHCARE INC.]3Unmatched20240216_ae8d2354-7ddb-41b8-9d55-77c84782b18f.zip