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_79b8336c-1ac6-4150-ad24-4ba74b980322
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125813AucatzylObecabtagene autoleucel351(a)Rx2026-06-01

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