NDC 71394-065 - LUXTURNA

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: 71394-065
Package NDCs from labels: 71394-065-01
Manufacturer: Spark Therapeutics, Inc. | BioReliance Corporation | Pharmaceutical Product Development, Inc. (PPD) | Absorption Systems | Eurofins (Lancaster Laboratories) | Intertek USA Inc | Nova Laboratories Ltd | Catalent CTS (Edinburgh) Limited | Tepnel Pharma Services Limited | Synergy Health Sterilisation UK Ltd.
Effective date: 2024-04-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LUXTURNA	Spark Therapeutics, Inc. \| BioReliance Corporation \| Pharmaceutical Product Development, Inc. (PPD) \| Absorption Systems \| Eurofins (Lancaster Laboratories) \| Intertek USA Inc \| Nova Laboratories Ltd \| Catalent CTS (Edinburgh) Limited \| Tepnel Pharma Services Limited \| Synergy Health Sterilisation UK Ltd.	2024-04-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71394-065-01	LUXTURNA	1 in 1 VIAL, PLASTIC	INJECTION, SUSPENSION	1	0.05 mg	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71394-065	LUXTURNA (VORETIGENE NEPARVOVEC-RZYL) KIT [SPARK THERAPEUTICS, INC.]	11	Unmatched	20240418_08313a24-e7ce-457a-bb3f-161bc45517ee.zip