FDA.reportPublic FDA data

NDC 0053-0099-01 - 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
Requested NDC
0053-0099-01
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMGENIXETRANACOGENE DEZAPARVOVECCSL Behring35b2db65-4c6c-4173-ab56-b2bca69193bd2026-05-01Warnings, Adverse reactionsExact identifier
application number: BLA125772
ndc (package): 0053-0250-25
ndc (package): 0053-0100-10
ndc (package): 0053-0190-19
ndc (package): 0053-0260-26
ndc (package): 0053-0290-29
ndc (package): 0053-0240-24
ndc (package): 0053-0160-16
ndc (package): 0053-0120-12
ndc (package): 0053-0450-45
ndc (package): 0053-0420-42
ndc (package): 0053-0320-32
ndc (package): 0053-0230-23
ndc (package): 0053-0350-35
ndc (package): 0053-0410-41
ndc (package): 0053-0110-11
ndc (package): 0053-0220-22
ndc (package): 0053-0280-28
ndc (package): 0053-0130-13
ndc (package): 0053-0440-44
ndc (package): 0053-0430-43
ndc (package): 0053-0460-46
ndc (package): 0053-0210-21
ndc (package): 0053-0480-48
ndc (package): 0053-0300-30
ndc (package): 0053-0200-20
ndc (package): 0053-0400-40
ndc (package): 0053-0330-33
ndc (package): 0053-0270-27
ndc (package): 0053-0470-47
ndc (package): 0053-0370-37
ndc (package): 0053-0180-18
ndc (package): 0053-0310-31
ndc (package): 0053-0390-39
ndc (package): 0053-0099-01
ndc (package): 0053-0140-14
ndc (package): 0053-0360-36
ndc (package): 0053-0170-17
ndc (package): 0053-0340-34
ndc (package): 0053-0150-15
ndc (package): 0053-0380-38
ndc (product): 0053-0330
ndc (product): 0053-0450
ndc (product): 0053-0170
ndc (product): 0053-0130
ndc (product): 0053-0460
ndc (product): 0053-0440
ndc (product): 0053-0380
ndc (product): 0053-0370
ndc (product): 0053-0340
ndc (product): 0053-0110
ndc (product): 0053-0220
ndc (product): 0053-0320
ndc (product): 0053-0150
ndc (product): 0053-0280
ndc (product): 0053-0210
ndc (product): 0053-0410
ndc (product): 0053-0230
ndc (product): 0053-0270
ndc (product): 0053-0430
ndc (product): 0053-0420
ndc (product): 0053-0140
ndc (product): 0053-0350
ndc (product): 0053-0260
ndc (product): 0053-0310
ndc (product): 0053-0290
ndc (product): 0053-0390
ndc (product): 0053-0120
ndc (product): 0053-0190
ndc (product): 0053-0360
ndc (product): 0053-0160
ndc (product): 0053-0400
ndc (product): 0053-0250
ndc (product): 0053-0470
ndc (product): 0053-0480
ndc (product): 0053-0240
ndc (product): 0053-0300
ndc (product): 0053-0200
ndc (product): 0053-0180
ndc (product): 0053-0100
ndc11 (package): 00053009901
rxcui: 2626838
rxcui: 2626803
rxcui: 2626806
rxcui: 2626824
rxcui: 2626782
rxcui: 2626790
rxcui: 2626850
rxcui: 2626814
rxcui: 2626858
rxcui: 2626818
rxcui: 2626815
rxcui: 2626789
rxcui: 2626778
rxcui: 2626781
rxcui: 2626845
rxcui: 2626840
rxcui: 2626849
rxcui: 2626836
rxcui: 2626831
rxcui: 2626811
rxcui: 2626794
rxcui: 2626783
rxcui: 2626823
rxcui: 2626791
rxcui: 2626835
rxcui: 2626808
rxcui: 2626810
rxcui: 2626785
rxcui: 2626795
rxcui: 2626812
rxcui: 2626844
rxcui: 2626859
rxcui: 2626809
rxcui: 2626798
rxcui: 2626807
rxcui: 2626805
rxcui: 2626813
rxcui: 2626829
rxcui: 2626852
rxcui: 2627142
rxcui: 2626820
rxcui: 2626784
rxcui: 2626846
rxcui: 2626830
rxcui: 2626855
rxcui: 2626816
rxcui: 2626817
rxcui: 2626804
rxcui: 2626857
rxcui: 2626780
rxcui: 2626834
rxcui: 2626786
rxcui: 2626822
rxcui: 2627141
rxcui: 2626853
rxcui: 2626819
rxcui: 2626797
rxcui: 2626793
rxcui: 2626837
rxcui: 2626860
rxcui: 2626832
rxcui: 2626833
rxcui: 2626802
rxcui: 2626787
rxcui: 2626792
rxcui: 2626788
rxcui: 2626772
rxcui: 2626847
rxcui: 2626856
rxcui: 2626825
rxcui: 2626843
rxcui: 2626800
rxcui: 2626796
rxcui: 2626799
rxcui: 2626801
rxcui: 2626839
rxcui: 2626848
rxcui: 2626851
rxcui: 2626854
rxcui: 2626821
spl id: 46103596-b3c5-48d1-9c04-dc7619864ffa
spl set id: 35b2db65-4c6c-4173-ab56-b2bca69193bd