FDA.reportPublic FDA data

HEMGENIX

Product NDC
0053-0100
11-digit product format
000530100
Labeler code
0053
Product ID
0053-0100_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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2626772, 2626778, 2626780, 2626781, 2626782, 2626783, 2626784, 2626785, 2626786, 2626787, 2626788, 2626789, 2626790, 2626791, 2626792, 2626793, 2626794, 2626795, 2626796, 2626797

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0053-0100-102025-09-12C16284748780-13b156c62-32a7-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 2022
0053-0100-102025-07-29C16284748780-13b156c62-32a7-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 2022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0053-0099-01HEMGENIX1 in 1 VIAL, GLASSINJECTION, SUSPENSION101013 {GC}8
0053-0100-10HEMGENIX1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0053-0100HEMGENIX (ETRANACOGENE DEZAPARVOVEC) KIT [CSL BEHRING]6Current NDC, 2 package rows20230517_35b2db65-4c6c-4173-ab56-b2bca69193bd.zip

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
0053-0100-10000530100101 KIT in 1 CARTON (0053-0100-10) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) 1 kit2022-11-22NoNoCurrent