FDA.reportPublic FDA data

AUCATZYL

Product NDC
83047-410
Requested package NDC
83047-410-04
11-digit product format
830470410
Labeler code
83047
Product ID
83047-410_5ff8c7fb-5a15-4817-bd53-ae3ea48d8449
Type
CELLULAR THERAPY
Nonproprietary name
Obecabtagene autoleucel
Dosage form
KIT
Labeler
Autolus Inc.
Application
BLA125813
Marketing category
BLA
Marketing start
2024-11-08
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
AUCATZYL
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2700168Internal RxNorm lookup
2700173Internal RxNorm lookup
2700174Internal RxNorm lookup
2700175Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fef6986-b988-45e4-8c20-b14f0ef1f538Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83047-010-10AUCATZYL1 in 1 BAGSUSPENSION1100000005
83047-100-10AUCATZYL1 in 1 BAGSUSPENSION11000000005
83047-100-30AUCATZYL1 in 1 BAGSUSPENSION11000000005
83047-300-30AUCATZYL1 in 1 BAGSUSPENSION13000000005
83047-410-04AUCATZYL1 in 1 PACKAGEKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83047-410-04EA - Each83047-410e7ed2af5-a9fa-48ac-9f44-1cbab6276bf312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83047-410AUCATZYL (OBECABTAGENE AUTOLEUCEL) KIT [AUTOLUS INC.]3Current NDC, 5 package rows20250321_4fef6986-b988-45e4-8c20-b14f0ef1f538.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AUCATZYLOBECABTAGENE AUTOLEUCELAutolus Inc.4fef6986-b988-45e4-8c20-b14f0ef1f5382026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125813
ndc (package): 83047-410-04
ndc (product): 83047-410
ndc11 (package): 83047041004

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125813AucatzylObecabtagene autoleucel351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700175{5 (obecabtagene autoleucel 410000000 CELLS/ML Injection [Aucatzyl]) } Pack [Aucatzyl Kit 3-5 Bags]BPCK4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700174{5 (obecabtagene autoleucel 410000000 CELLS/ML Injection) } PackGPCK4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700173Aucatzyl 410000000 CELLS/ML InjectionPSN4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700175Aucatzyl Kit 3-5 BagsPSN4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700168obecabtagene autoleucel 410000000 CELLS/ML InjectionPSN4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700174obecabtagene autoleucel Kit 3-5 BagPSN4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700173obecabtagene autoleucel 410000000 CELLS/ML Injection [Aucatzyl]SBD4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700168obecabtagene autoleucel 410000000 CELLS/ML InjectionSCD4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700173Aucatzyl 410000000 CELLS/ML InjectionSY4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700175Aucatzyl Kit 3-5 BagsSY4fef6986-b988-45e4-8c20-b14f0ef1f5385
2700174obecabtagene autoleucel Kit 3-5 BagSY4fef6986-b988-45e4-8c20-b14f0ef1f5385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83047-410-04830470410041 KIT in 1 PACKAGE (83047-410-04) * 1 SUSPENSION in 1 BAG (83047-100-30) * 1 SUSPENSION in 1 BAG (83047-100-10) * 1 SUSPENSION in 1 BAG (83047-300-30) * 1 SUSPENSION in 1 BAG (83047-010-10) 1 kit2024-11-08NoNoCurrent