Home NDC 73554-1111 Lyfgenia
Product NDC 73554-1111
11-digit product format 735541111
Labeler code 73554
Product ID 73554-1111_7e6dc606-b12b-4804-a746-ae47b5e18c43
Type CELLULAR THERAPY
Nonproprietary name lovotibeglogene autotemcel
Dosage form SUSPENSION
Route INTRAVENOUS
Labeler Genetix Biotherapeutics Inc.
Application BLA125788
Marketing category BLA
Marketing start 2023-12-08
Substance LOVOTIBEGLOGENE AUTOTEMCEL
Active strength 20000000 1/20mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lyfgenia
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOVOTIBEGLOGENE AUTOTEMCEL 20000000 1/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2C6A9NH2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2672691 Internal RxNorm lookup 2672697 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73554-1111-1 Lyfgenia 1 mL in 1 BAG SUSPENSION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73554-1111 LYFGENIA (LOVOTIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.] 5 Current NDC, 1 package rows 20240907_0d1b475e-5781-2bd1-e063-6294a90a7311.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 Lyfgenia LOVOTIBEGLOGENE AUTOTEMCEL Genetix Biotherapeutics Inc. 0d1b475e-5781-2bd1-e063-6294a90a7311 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125788 ndc (product): 73554-1111
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125788 LYFGENIA lovotibeglogene autotemcel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2672691 lovotibeglogene autotemcel 20,000,000 CELLS/ML in 20 ML Injection PSN 0d1b475e-5781-2bd1-e063-6294a90a7311 7 2672697 lyfgenia 20,000,000 CELLS/ML in 20 ML Injection PSN 0d1b475e-5781-2bd1-e063-6294a90a7311 7 2672697 20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia] SBD 0d1b475e-5781-2bd1-e063-6294a90a7311 7 2672691 20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection SCD 0d1b475e-5781-2bd1-e063-6294a90a7311 7 2672691 lovotibeglogene autotemcel 20,000,000 CELLS/ML per 20 ML Injection SY 0d1b475e-5781-2bd1-e063-6294a90a7311 7 2672697 Lyfgenia 20,000,000 CELLS/ML per 20 ML Injection SY 0d1b475e-5781-2bd1-e063-6294a90a7311 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73554-1111-1 73554111101 1 mL in 1 BAG (73554-1111-1) 1 ml 2023-12-08 No No Current