FDA.reportPublic FDA data

NDC 83047-300 - 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
83047-300
Package NDCs from labels
83047-300-30
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
83047-300-30AUCATZYL1 in 1 BAGSUSPENSION13000000005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83047-300AUCATZYL (OBECABTAGENE AUTOLEUCEL) KIT [AUTOLUS INC.]3Unmatched20250321_4fef6986-b988-45e4-8c20-b14f0ef1f538.zip

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 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
rxcui: 2700168
rxcui: 2700175
rxcui: 2700173
rxcui: 2700174
spl id: 5ff8c7fb-5a15-4817-bd53-ae3ea48d8449
spl set id: 4fef6986-b988-45e4-8c20-b14f0ef1f538