HEMGENIX

Product NDC
0053-0230
11-digit product format
000530230
Labeler code
0053
Product ID
0053-0230_46103596-b3c5-48d1-9c04-dc7619864ffa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etranacogene dezaparvovec
Dosage form
KIT
Labeler
CSL Behring
Application
BLA125772
Marketing category
BLA
Marketing start
2022-11-22
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct0053-0230IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0053-02300053-0230-23IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Additional Listing Data#

Finished product
Yes
Brand name base
HEMGENIX
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 4 · 80 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2626772Internal RxNorm lookup
2626778Internal RxNorm lookup
2626780Internal RxNorm lookup
2626781Internal RxNorm lookup
2626782Internal RxNorm lookup
2626783Internal RxNorm lookup
2626784Internal RxNorm lookup
2626785Internal RxNorm lookup
2626786Internal RxNorm lookup
2626787Internal RxNorm lookup
2626788Internal RxNorm lookup
2626789Internal RxNorm lookup
2626790Internal RxNorm lookup
2626791Internal RxNorm lookup
2626792Internal RxNorm lookup
2626793Internal RxNorm lookup
2626794Internal RxNorm lookup
2626795Internal RxNorm lookup
2626796Internal RxNorm lookup
2626797Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35b2db65-4c6c-4173-ab56-b2bca69193bdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION231013 {GC}8
0053-0230-23HEMGENIX1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0053-0230-23EA - Each0053-0230c30e9279-1ec4-4f4e-a5f4-6b1279cc1a7c12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0053-0230HEMGENIX (ETRANACOGENE DEZAPARVOVEC) KIT [CSL BEHRING]6Current NDC, 2 package rows20230517_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 · 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 (product): 0053-0230

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125772Hemgenixetranacogene dezaparvovec-drlb351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626781{10 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 46 - 50 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626783{11 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 51 - 55 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626785{12 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 56 - 60 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626787{13 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 61 - 65 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626789{14 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 66 - 70 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626791{15 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 71 - 75 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626793{16 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 76 - 80 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626795{17 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 81 - 85 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626797{18 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 86 - 90 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626799{19 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 91 - 95 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626801{20 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 96 - 100 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626803{21 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 101 - 105 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626805{22 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 106 - 110 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626807{23 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 111 - 115 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626809{24 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 116 - 120 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626811{25 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 121 - 125 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626813{26 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 126 - 130 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626815{27 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 131 - 135 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626817{28 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 136 - 140 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626819{29 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 141 - 145 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626830{30 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 146 - 150 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626832{31 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 151 - 155 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626834{32 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 156 - 160 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626836{33 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 161 - 165 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626838{34 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 166 - 170 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626840{35 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 171 - 175 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2627142{36 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 176 - 180 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626844{37 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 181 - 185 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626846{38 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 186 - 190 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626848{39 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 191 - 195 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626860{40 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 196 - 200 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626858{41 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 201 - 205 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626856{42 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 206 - 210 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626854{43 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 211 - 215 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626852{44 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 216 - 220 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626850{45 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 221 - 225 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626825{46 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 226 - 230 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626823{47 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 231 - 235 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626821{48 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 236 - 240 KG]BPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626780{10 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626782{11 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626784{12 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626786{13 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626788{14 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626790{15 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626792{16 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626794{17 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626796{18 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626798{19 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626800{20 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626802{21 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626804{22 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626806{23 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626808{24 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626810{25 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626812{26 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626814{27 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626816{28 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626818{29 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626829{30 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626831{31 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626833{32 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626835{33 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626837{34 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626839{35 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2627141{36 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626843{37 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626845{38 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626847{39 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626859{40 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626857{41 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626855{42 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626853{43 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626851{44 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626849{45 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626824{46 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626822{47 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626820{48 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626772etranacogene dezaparvovec-drlb 100000000000000 VECTOR-GENOMES in 10 ML InjectionPSN35b2db65-4c6c-4173-ab56-b2bca69193bd8
2626802etranacogene dezaparvovec-drlb Kit Patient Weight 101 - 105 KGPSN35b2db65-4c6c-4173-ab56-b2bca69193bd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0053-0099-01000530099011 in 1 VIAL, GLASSHistorical
0053-0230-23000530230231 KIT in 1 CARTON (0053-0230-23) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) 1 kit2022-11-22NoNoCurrent