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 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.
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
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 2026-06-01
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