FDA.reportPublic FDA data

NDC 83047-100-30 - AUCATZYL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83047-100
Requested NDC
83047-100-30
Package NDCs from labels
83047-100-10, 83047-100-30
Manufacturer
Autolus Inc. | Autolus Limited
Effective date
2026-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AUCATZYL - Autolus Inc. | Autolus LimitedAutolus Inc. | Autolus Limited2026-06-23CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83047-100-10AUCATZYL1 in 1 BAGSUSPENSION11000000005
83047-100-30AUCATZYL1 in 1 BAGSUSPENSION11000000005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83047-100AUCATZYL (OBECABTAGENE AUTOLEUCEL) KIT [AUTOLUS INC.]3Unmatched20250321_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 ยท 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): 83047-300-30
ndc (package): 83047-410-04
ndc (package): 83047-100-10
ndc (package): 83047-010-10
ndc (package): 83047-100-30
ndc (product): 83047-410
ndc11 (package): 83047010030
rxcui: 2700168
rxcui: 2700175
rxcui: 2700173
rxcui: 2700174
spl id: 5ff8c7fb-5a15-4817-bd53-ae3ea48d8449
spl set id: 4fef6986-b988-45e4-8c20-b14f0ef1f538

Reported adverse events (FAERS/openFDA)#

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