NDC 73554-1111-01 - Lyfgenia

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
73554-1111
Requested NDC
73554-1111-01
Package NDCs from labels
73554-1111-1, 73554-1111-01
Manufacturer
Genetix Biotherapeutics Inc. | Minaris Regenerative Medicine, LLC
Effective date
2026-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lyfgenia - Genetix Biotherapeutics Inc. | Minaris Regenerative Medicine, LLCGenetix Biotherapeutics Inc. | Minaris Regenerative Medicine, LLC2026-07-21CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73554-1111-1Lyfgenia1 mL in 1 BAGSUSPENSION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73554-1111LYFGENIA (LOVOTIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.]5Current NDC, 1 package rows20240907_0d1b475e-5781-2bd1-e063-6294a90a7311.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73554-1111-1EA - Each73554-11114d6971c6-6c74-45ae-a6af-983b5f19cd1012024-01-04

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LyfgeniaLOVOTIBEGLOGENE AUTOTEMCELGenetix Biotherapeutics Inc.0d1b475e-5781-2bd1-e063-6294a90a73112026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125788
ndc (package): 73554-1111-1
ndc (product): 73554-1111
ndc11 (package): 73554111101
rxcui: 2672697
rxcui: 2672691
spl id: 7e6dc606-b12b-4804-a746-ae47b5e18c43
spl set id: 0d1b475e-5781-2bd1-e063-6294a90a7311
unii: 2C6A9NH2Z8

Reported adverse events (FAERS/openFDA)#

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