Kresladi Injection, Suspension
NDC 83537-034
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Kresladi (marnetegragene autotemcel) is a BLA-approved product labeled by Rocket Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection, suspension for intravenous administration. This product entry covers the primary NDC 83537-034 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
83537-034
Proprietary Name:
Kresladi
Non-Proprietary Name: [1]
Marnetegragene Autotemcel
Substance Name: [2]
Marnetegragene Autotemcel
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Suspension
- A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
83537
Product Label ID:
FDA Application Number: [6]
BLA125806
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
03-26-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 83537-034?
The NDC code 83537-034 is assigned by the FDA to the product Kresladi. It is commonly known by its generic name, marnetegragene autotemcel. This pharmaceutical product is labeled by Rocket Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a injection, suspension administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 83537-034-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
KRESLADI is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant.This indication is approved under accelerated approval based on increase in neutrophil CD18 and CD11a surface expression [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- MARNETEGRAGENE AUTOTEMCEL (UNII: RD86XHH46N)
- MARNETEGRAGENE AUTOTEMCEL (UNII: RD86XHH46N) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2740386 - marnetegragene autotemcel 6,100,000 CELLS/ML in 30 ML Injection
- RxCUI: 2740386 - 30 ML marnetegragene autotemcel 6100000 CELLS/ML Injection
- RxCUI: 2740386 - marnetegragene autotemcel 6,100,000 CELLS/ML per 30 ML Injection
- RxCUI: 2740392 - KRESLADI 6,100,000 CELLS/ML in 30 ML Injection
- RxCUI: 2740392 - 30 ML marnetegragene autotemcel 6100000 CELLS/ML Injection [Kresladi]
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
