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HEMGENIX

These 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

Approved
Approval ID

35b2db65-4c6c-4173-ab56-b2bca69193bd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 4, 2023

Manufacturers
FDA

CSL Behring

DUNS: 058268293

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0360
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0400
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0190
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0240
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0120
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0300
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0250
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0290
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0380
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

etranacogene dezaparvovec

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0053-0480
Application NumberBLA125772
Product Classification
M
Marketing Category
C73585
G
Generic Name
etranacogene dezaparvovec
Product Specifications
Effective DateDecember 27, 2022
FDA Product Classification

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