Home NDC 83537-034 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RD86XHH46N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2740386 Internal RxNorm lookup 2740392 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KRESLADI MARNETEGRAGENE AUTOTEMCEL Rocket Pharmaceuticals, Inc. 97db9c3c-20c2-4dad-890c-bc821805421f 2026-07-01 Warnings, Adverse reactions Exact identifier application number: BLA125806 ndc (product): 83537-034
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125806 kresladi marnetegragene autotemcel 351(a) Rx 2026-08-01
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