Kresladi Injection, Suspension
NDC Package 83537-034-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Kresladi (marnetegragene autotemcel) injection is 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)]. This formulation utilizes a injection, suspension delivery system. Marketed by Rocket Pharmaceuticals, Inc., this product is identified by NDC 83537-034 and is authorized under FDA application BLA125806.

Identification & Billing

NDC Package Code
83537-034-01
Package Description
30 mL in 1 BAG
Product Code
83537-034
11-Digit Billing Format
83537003401
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Kresladi
Non-Proprietary Name
Marnetegragene Autotemcel
Substance Name
Marnetegragene Autotemcel
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MARNETEGRAGENE AUTOTEMCEL 6100000 1/mL
Usage Information
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).

Regulatory & Marketing

Labeler Name
Rocket Pharmaceuticals, Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125806
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-26-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83537-034-01 identifies a specific commercial package of 30 ml in 1 bag of Kresladi, a cellular therapy labeled by Rocket Pharmaceuticals, Inc.. This injection, suspension is formulated for intravenous use and contains marnetegragene autotemcel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rocket Pharmaceuticals, Inc. on March 26, 2026. The current certification is valid through December 31, 2027.

How is this Rocket Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83537003401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83537-034-01
11-Digit CMS (5-4-2)
83537-0034-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.