KRESLADI
- Product NDC
- 83537-034
- 11-digit product format
- 835370034
- Labeler code
- 83537
- Product ID
- 83537-034_732a1900-dc5c-4247-b352-6422eeb7351f
- Type
- CELLULAR THERAPY
- Nonproprietary name
- MARNETEGRAGENE AUTOTEMCEL
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Rocket Pharmaceuticals, Inc.
- Application
- BLA125806
- Marketing category
- BLA
- Marketing start
- 2026-03-26
- Substance
- MARNETEGRAGENE AUTOTEMCEL
- Active strength
- 6100000 1/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KRESLADI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MARNETEGRAGENE AUTOTEMCEL | 6100000 1/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RD86XHH46N |
| Rxcui | 2740386, 2740392 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83537-034-01 | KRESLADI | 30 mL in 1 BAG | INJECTION, SUSPENSION | 30 | | 2 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2740392 | KRESLADI 6,100,000 CELLS/ML in 30 ML Injection | PSN | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740386 | marnetegragene autotemcel 6,100,000 CELLS/ML in 30 ML Injection | PSN | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740392 | 30 ML marnetegragene autotemcel 6100000 CELLS/ML Injection [Kresladi] | SBD | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740386 | 30 ML marnetegragene autotemcel 6100000 CELLS/ML Injection | SCD | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740392 | 30 ML Kresladi 6100000 CELLS/ML Injection | SY | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740392 | KRESLADI 6,100,000 CELLS/ML per 30 ML Injection | SY | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
| 2740386 | marnetegragene autotemcel 6,100,000 CELLS/ML per 30 ML Injection | SY | 97db9c3c-20c2-4dad-890c-bc821805421f | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83537-034-01 | 83537003401 | 30 mL in 1 BAG (83537-034-01) | 30 ml | 2026-03-26 | No | No | Current |