Home NDC 73539-001 LANTIDRA
Product NDC 73539-001
11-digit product format 735390001
Labeler code 73539
Product ID 73539-001_a3163e14-0404-4e27-884b-f6f9f7f695bc
Type CELLULAR THERAPY
Nonproprietary name DONISLECEL
Dosage form SOLUTION
Route INTRAVASCULAR
Labeler CellTrans Inc.
Application BLA125734
Marketing category BLA
Marketing start 2023-06-28
Substance DONISLECEL
Active strength 5000 [arb'U]/400mL
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 LANTIDRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONISLECEL 5000 [arb'U]/400mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FW00DG4E3P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2642264 Internal RxNorm lookup 2642270 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73539-001-01 LANTIDRA 400 mL in 1 BAG SOLUTION 400 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73539-001 LANTIDRA (DONISLECEL) SOLUTION [CELLTRANS INC.] 2 Current NDC, 1 package rows 20241206_24610d9f-0c5a-4f55-93b3-d456300bfd5d.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125734 Lantidra donislecel-jujn 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73539-001-01 73539000101 400 mL in 1 BAG (73539-001-01) 400 ml 2023-06-28 No No Current