Home NDC 57894-111 CARVYKTI
Product NDC 57894-111
11-digit product format 578940111
Labeler code 57894
Product ID 57894-111_b911e9ec-28f1-4ddc-b0b9-49086f83300b
Type CELLULAR THERAPY
Nonproprietary name ciltacabtagene autoleucel
Dosage form INJECTION, SUSPENSION
Route INTRAVENOUS
Labeler Janssen Biotech, Inc.
Application BLA125746
Marketing category BLA
Marketing start 2022-02-28
Substance CILTACABTAGENE AUTOLEUCEL
Active strength 100000000 1/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base CARVYKTI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CILTACABTAGENE AUTOLEUCEL 100000000 1/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0L1F17908Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2594780 Internal RxNorm lookup 2594786 Internal RxNorm lookup 2594789 Internal RxNorm lookup 2594792 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 57894-111-01 CARVYKTI 1 in 1 BAG INJECTION, SUSPENSION 1 17 57894-111-02 CARVYKTI 1 in 1 BAG INJECTION, SUSPENSION 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-111 CARVYKTI (CILTACABTAGENE AUTOLEUCEL) INJECTION, SUSPENSION [JANSSEN BIOTECH, INC] 13 Current NDC, Legacy NDC, 2 package rows 20240706_7d040b91-3fb8-41db-ba7f-60a36f06e2c2.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 CARVYKTI CILTACABTAGENE AUTOLEUCEL Janssen Biotech, Inc. 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125746 ndc (product): 57894-111
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125746 Carvykti ciltacabtagene autoleucel 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2594792 CARVYKTI 100,000,000 CELLS in 30 ML Injection PSN 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594786 CARVYKTI 100,000,000 CELLS in 70 ML Injection PSN 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594789 ciltacabtagene autoleucel 100,000,000 CELLS in 30 ML Injection PSN 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594780 ciltacabtagene autoleucel 100,000,000 CELLS in 70 ML Injection PSN 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594792 30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection [Carvykti] SBD 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594786 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection [Carvykti] SBD 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594789 30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection SCD 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594780 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection SCD 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594792 30 ML Carvykti 3330000 CELLS/ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594786 70 ML Carvykti 1430000 CELLS/ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594792 Carvykti 100,000,000 CELLS per 30 ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594786 Carvykti 100,000,000 CELLS per 70 ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594789 ciltacabtagene autoleucel 100,000,000 CELLS per 30 ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17 2594780 ciltacabtagene autoleucel 100,000,000 CELLS per 70 ML Injection SY 7d040b91-3fb8-41db-ba7f-60a36f06e2c2 17
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57894-111-01 57894011101 1 INJECTION, SUSPENSION in 1 BAG (57894-111-01) 2022-02-28 0000-00-00 No No Current 57894-111-02 57894011102 1 INJECTION, SUSPENSION in 1 BAG (57894-111-02) 2022-02-28 0000-00-00 No No Current