Cellular therapy · BLA
Kresladi (Marnetegragene autotemcel) NDC 83537-034
Marnetegragene autotemcel 6100000 1/mL · Injection, Suspension · Intravenous · Rocket Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83537-034-01 | 83537003401 | 30 mL in 1 BAG (83537-034-01)Marketed from Mar 26, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Kresladi
- Generic name (nonproprietary)
- marnetegragene autotemcel
- Active ingredients
- Marnetegragene autotemcel — 6100000 1/mL
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- Rocket Pharmaceuticals, Inc.NDC labeler code 83537
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125806
- Marketing start
- Listing expires
- Identifiers
- Product ID 83537-034_0f02e553-d27a-4e0c-a5b5-8192e06de49fSPL ID 0f02e553-d27a-4e0c-a5b5-8192e06de49fSPL set ID 97db9c3c-20c2-4dad-890c-bc821805421fRxCUI 2740386, 2740392UNII RD86XHH46N
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N483537003401followed by a unit qualifier and the quantityPackage 83537-0034-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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). KRESLADI is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients with severe leukoc…
Excerpt only. Read the full label for complete information.
About NDC 83537-034
- What is NDC 83537-034?
- 83537-034 is the product NDC for Kresladi (marnetegragene autotemcel), Marnetegragene autotemcel 6100000 1/mL injection, suspension, listed with the FDA by Rocket Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kresladi (Marnetegragene autotemcel).
- What is the active ingredient?
- Marnetegragene autotemcel.
- Who is the labeler?
- Rocket Pharmaceuticals, Inc., NDC labeler code 83537. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kresladi?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.