FDA.reportPublic FDA data

NDC 68135-061 - VOXZOGO 0.4mg

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
68135-061
Package NDCs from labels
68135-061-00
Manufacturer
BioMarin Pharmaceutical Inc.
Effective date
2025-11-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VOXZOGO 0.4mg - BioMarin Pharmaceutical Inc.BioMarin Pharmaceutical Inc.2025-11-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-061-00VOXZOGO 0.4mg10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,0.4 mg in 0.5mL16
68135-061-00VOXZOGO 0.4mg0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,5 mL0.4 mg in 0.5mL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-061VOXZOGO 0.4MG (VOSORITIDE) KIT VOXZOGO 0.56MG (VOSORITIDE) KIT VOXZOGO 1.2MG (VOSORITIDE) KIT [BIOMARIN PHARMACEUTICAL INC.]15Unmatched20241220_228e8560-04a4-4bb1-a81f-29531a9e4d27.zip