FDA.reportPublic FDA data

NDC 83047-100 - 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
Package NDCs from labels
83047-100-10, 83047-100-30
Manufacturer
Autolus Inc. | Autolus Limited
Effective date
2026-02-27
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 Limited2026-02-27CELLULAR 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