NDC 83047-010 - 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: 83047-010
Package NDCs from labels: 83047-010-10
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
Label	Manufacturer	Effective date	Type
AUCATZYL - Autolus Inc. \| Autolus Limited	Autolus Inc. \| Autolus Limited	2026-06-23	CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83047-010-10	AUCATZYL	1 in 1 BAG	SUSPENSION	1	10000000	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83047-010	AUCATZYL (OBECABTAGENE AUTOLEUCEL) KIT [AUTOLUS INC.]	3	Unmatched	20250321_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AUCATZYL	OBECABTAGENE AUTOLEUCEL	Autolus Inc.	4fef6986-b988-45e4-8c20-b14f0ef1f538	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact 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

Reported adverse events (FAERS/openFDA)#

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