FDA.reportPublic FDA data

NDC 0053-0099 - HEMGENIX

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
0053-0099
Package NDCs from labels
0053-0099-01
Manufacturer
CSL Behring | CSL Behring LLC
Effective date
2026-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HEMGENIX - CSL Behring | CSL Behring LLCCSL Behring | CSL Behring LLC2026-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION191013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION271013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION151013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION321013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION241013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION221013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION441013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION411013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION211013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION351013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION381013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION431013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION471013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION111013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION251013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION421013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION401013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION481013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION181013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION171013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION261013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION311013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION231013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION201013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION131013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION451013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION371013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION391013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION331013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION121013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION281013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION101013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION161013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION461013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION341013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION141013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION291013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION361013 {GC}8
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION301013 {GC}8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0053-0099HEMGENIX (ETRANACOGENE DEZAPARVOVEC) KIT [CSL BEHRING]6Unmatched20230517_35b2db65-4c6c-4173-ab56-b2bca69193bd.zip