Home NDC 73554-1111 Lyfgenia
Product NDC 73554-1111
11-digit product format 735541111
Labeler code 73554
Product ID 73554-1111_35e89ce3-d947-47dc-971c-8450f3afe4a8
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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 2026-06-01
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