NDC 73554-3111-01 - Zynteglo

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: 73554-3111
Requested NDC: 73554-3111-01
Package NDCs from labels: 73554-3111-1, 73554-3111-01
Manufacturer: Genetix Biotherapeutics Inc. | Lonza Houston, Inc
Effective date: 2026-07-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Zynteglo - Genetix Biotherapeutics Inc. \| Lonza Houston, Inc	Genetix Biotherapeutics Inc. \| Lonza Houston, Inc	2026-07-21	CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73554-3111-1	Zynteglo	1 in 1 BAG	SUSPENSION	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73554-3111	ZYNTEGLO (BETIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231207_86931613-c262-47f5-8202-bc31fa69ad3d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73554-3111-1	EA - Each	73554-3111	1a10af94-9605-40ae-af54-7f7ab70134ec	1	2022-09-12

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
Zynteglo	BETIBEGLOGENE AUTOTEMCEL	Genetix Biotherapeutics Inc.	86931613-c262-47f5-8202-bc31fa69ad3d	2026-07-21	Warnings, Adverse reactions	Exact identifier application number: BLA125717 ndc (package): 73554-3111-1 ndc (product): 73554-3111 ndc11 (package): 73554311101 rxcui: 2610436 rxcui: 2610435 spl id: ad3b5513-b7ff-492d-ad78-ea5a4bd44510 spl set id: 86931613-c262-47f5-8202-bc31fa69ad3d unii: MEE8487RTP

Reported adverse events (FAERS/openFDA)#

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