Home NDC 51167-290 CASGEVY
Product NDC 51167-290
11-digit product format 511670290
Labeler code 51167
Product ID 51167-290_524ddbe0-e4ac-4619-afc1-b5829bf8394c
Type CELLULAR THERAPY
Nonproprietary name exagamglogene autotemcel
Dosage form INJECTION, SUSPENSION
Route INTRAVENOUS
Labeler Vertex Pharmaceuticals Incorporated
Application BLA125787
Marketing category BLA
Marketing start 2023-12-08
Substance EXAGAMGLOGENE AUTOTEMCEL
Active strength 13000000 1/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base CASGEVY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EXAGAMGLOGENE AUTOTEMCEL 13000000 1/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S53L777GM8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671671 Internal RxNorm lookup 2671677 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 51167-290-01 CASGEVY 20 mL in 1 VIAL INJECTION, SUSPENSION 20 13 51167-290-09 CASGEVY 9 in 1 CARTON INJECTION, SUSPENSION 9 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51167-290 CASGEVY (EXAGAMGLOGENE AUTOTEMCEL) INJECTION, SUSPENSION [VERTEX PHARMACEUTICALS INCORPORATED] 6 Current NDC, 2 package rows 20240823_7c3e12ad-e2fe-4d3f-a630-ea7364d9e846.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 CASGEVY EXAGAMGLOGENE AUTOTEMCEL Vertex Pharmaceuticals Incorporated 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 2026-07-07 Warnings, Adverse reactions Exact identifier application number: BLA125787 ndc (product): 51167-290
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125787 Casgevy Exagamglogene autotemcel 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2671677 casgevy 13,000,000 CELLS/mL in 1.5 ML Injection PSN 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671671 exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection PSN 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671677 1.5 ML exagamglogene autotemcel 13000000 CELLS/ML Injection [Casgevy] SBD 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671671 1.5 ML exagamglogene autotemcel 13000000 CELLS/ML Injection SCD 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671677 1.5 ML Casgevy 13000000 CELLS/ML Injection SY 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671677 Casgevy 13,000,000 CELLS/ML per 1.5 ML Injection SY 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13 2671671 exagamglogene autotemcel 13,000,000 CELLS/ML per 1.5 ML Injection SY 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51167-290-01 51167029001 20 mL in 1 VIAL 20 ml Historical 51167-290-09 51167029009 9 VIAL in 1 CARTON (51167-290-09) / 20 mL in 1 VIAL (51167-290-01) 9 vial 2023-12-08 No No Current