FDA.reportPublic FDA data

NDC 63459-307 - HERZUMA

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
63459-307
Package NDCs from labels
63459-307-41
Manufacturer
Cephalon, Inc. | CELLTRION, Inc.
Effective date
2025-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HERZUMA - Cephalon, Inc. | CELLTRION, Inc.Cephalon, Inc. | CELLTRION, Inc.2025-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-307-41HERZUMA50 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,50 mL420 mg in 20mL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-307HERZUMA (TRASTUZUMAB) KIT HERZUMA (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INC.]13Unmatched20250419_ae71c003-883a-4cd8-ad50-e8cc9a54e971.zip