NDC Product
Human Prescription DrugHemgenix NDC 0053-0100
- Generic Name
- Etranacogene Dezaparvovec
- Dosage Form
- Kit
- Route
- N/A
- Marketing
- BLA
Active Listing
ETRANACOGENE DEZAPARVOVEC
UNII Z5XCD5Q9RL
Substance Identification & Data
This profile provides standardized clinical and technical data for Etranacogene Dezaparvovec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Z5XCD5Q9RL.
Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2156583-26-3 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.
Z5XCD5Q9RL
2156583-26-3
N/A
Detailed Substance Profile
Preferred Name
ETRANACOGENE DEZAPARVOVEC
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
Z5XCD5Q9RL
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
National Cancer Institute reference terminology for clinical and research data.
INN ID
10963
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
JK-202
Identifier assigned by the United States Adopted Names Council.
Substance Type
structurallyDiverse
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Synonyms and Nomenclature
This section provides a complete list of nomenclature and identifier mappings for Etranacogene Dezaparvovec. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.
FDA Official Name
ETRANACOGENE DEZAPARVOVEC
ETRANACOGENE DEZAPARVOVEC-DLRB
Common Names & Synonyms
ETRANACOGENE DEZAPARVOVEC [INN]
ETRANACOGENE DEZAPARVOVEC [USAN]
ETRANACOGENE DEZAPARVOVEC [WHO-DD]
Brand / Trade Names
HEMGENIX
Systematic Nomenclature
RECOMBINANT NON-REPLICATING ADENO-ASSOCIATED VIRUS SEROTYPE 5 (AAV5) EXPRESSING THE PADUA VARIANT (R338L) OF HUMAN COAGULAN FACTOR IX (F9, FACTOR IX, OR FIX), UNDER THE CONTROL OF THE LIVER-SPECIFIC PROMOTER (LP1)THE GENOMIC INVERTED TERMINAL REPEATS (ITR) ARE DERIVED FROM AAV SEROTYPE 2 (AAV2) ITR WHILE THE VECTOR IS ENCAPSIDATED IN A SEROTYPE 5 AAV PROTEIN CAPSID.
Technical Codes
AAV5-HFIXCO-PADUA
AMT-061
NDC Products Containing ETRANACOGENE DEZAPARVOVEC
This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:
