FDA.reportPublic FDA data

RYONCIL

Product NDC
73648-113
11-digit product format
736480113
Labeler code
73648
Product ID
73648-113_59dc6f33-2845-4182-81ae-04d34d7f2204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
remestemcel-l-rknd
Dosage form
KIT
Labeler
Mesoblast
Application
BLA125706
Marketing category
BLA
Marketing start
2025-03-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RYONCIL
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2700771, 2700778, 2706549, 2706550, 2706551, 2706552, 2706553, 2706554, 2706555, 2706556, 2706557, 2706558, 2706559, 2706560, 2706561, 2706562, 2706563, 2706564, 2723916

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73648-113-03RYONCIL1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73648-113RYONCIL (REMESTEMCEL-L-RKND) KIT [MESOBLAST]4Current NDC, 1 package rows20250429_a4e0918f-7444-4694-adeb-d38d98345659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2706550{1 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit < 12.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2723919{10 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 112.5 - < 125 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2723921{11 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 125 - < 137.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2723923{12 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 137.5 - < 150 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706552{2 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 12.5 - < 25 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706554{3 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 25 - < 37.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706556{4 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 37.5 - < 50 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706558{5 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 50 - < 62.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706560{6 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 62.5 - < 75 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706562{7 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 75 - < 87.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706564{8 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 87.5 - < 100 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2723917{9 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 100 - < 112.5 kg]BPCKa4e0918f-7444-4694-adeb-d38d983456595
2706549{1 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2723918{10 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2723920{11 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2723922{12 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706551{2 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706553{3 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706555{4 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706557{5 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706559{6 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706561{7 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2706563{8 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
2723916{9 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } PackGPCKa4e0918f-7444-4694-adeb-d38d983456595
797544isopropyl alcohol 70 % Medicated PadPSNa4e0918f-7444-4694-adeb-d38d983456595
2700771remestemcel-L-rknd 25,000,000 CELLS in 3.8 ML InjectionPSNa4e0918f-7444-4694-adeb-d38d983456595
2706549remestemcel-L-rknd Kit Patient Weight < 12.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723916remestemcel-L-rknd Kit Patient Weight 100 - < 112.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723918remestemcel-L-rknd Kit Patient Weight 112.5 - < 125 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706551remestemcel-L-rknd Kit Patient Weight 12.5 - < 25 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723920remestemcel-L-rknd Kit Patient Weight 125 - < 137.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723922remestemcel-L-rknd Kit Patient Weight 137.5 - < 150 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706553remestemcel-L-rknd Kit Patient Weight 25 - < 37.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706555remestemcel-L-rknd Kit Patient Weight 37.5 - < 50 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706557remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706559remestemcel-L-rknd Kit Patient Weight 62.5 - < 75 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706561remestemcel-L-rknd Kit Patient Weight 75 - < 87.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706563remestemcel-L-rknd Kit Patient Weight 87.5 - < 100 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2700778Ryoncil 25,000,000 CELLS in 3.8 ML InjectionPSNa4e0918f-7444-4694-adeb-d38d983456595
2706550Ryoncil Kit Patient Weight < 12.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723917Ryoncil Kit Patient Weight 100 - < 112.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723919Ryoncil Kit Patient Weight 112.5 - < 125 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706552Ryoncil Kit Patient Weight 12.5 - < 25 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723921Ryoncil Kit Patient Weight 125 - < 137.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2723923Ryoncil Kit Patient Weight 137.5 - < 150 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706554Ryoncil Kit Patient Weight 25 - < 37.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706556Ryoncil Kit Patient Weight 37.5 - < 50 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706558Ryoncil Kit Patient Weight 50 - < 62.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706560Ryoncil Kit Patient Weight 62.5 - < 75 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706562Ryoncil Kit Patient Weight 75 - < 87.5 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
2706564Ryoncil Kit Patient Weight 87.5 - < 100 KGPSNa4e0918f-7444-4694-adeb-d38d983456595
27007783.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]SBDa4e0918f-7444-4694-adeb-d38d983456595
27007713.8 ML remestemcel-L-rknd 6680000 CELLS/ML InjectionSCDa4e0918f-7444-4694-adeb-d38d983456595
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa4e0918f-7444-4694-adeb-d38d983456595
27007783.8 ML Ryoncil 6680000 CELLS/ML InjectionSYa4e0918f-7444-4694-adeb-d38d983456595
797544isopropyl alcohol 70 % Medicated PadSYa4e0918f-7444-4694-adeb-d38d983456595
797544isopropyl alcohol 70 % Topical ClothSYa4e0918f-7444-4694-adeb-d38d983456595
797544isopropyl alcohol 70 % Topical SwabSYa4e0918f-7444-4694-adeb-d38d983456595
2700771remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML InjectionSYa4e0918f-7444-4694-adeb-d38d983456595
2706549remestemcel-L-rknd Kit Patient Weight < 12.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723916remestemcel-L-rknd Kit Patient Weight 100 - < 112.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723918remestemcel-L-rknd Kit Patient Weight 112.5 - < 125 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706551remestemcel-L-rknd Kit Patient Weight 12.5 - < 25 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723920remestemcel-L-rknd Kit Patient Weight 125 - < 137.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723922remestemcel-L-rknd Kit Patient Weight 137.5 - < 150 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706553remestemcel-L-rknd Kit Patient Weight 25 - < 37.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706555remestemcel-L-rknd Kit Patient Weight 37.5 - < 50 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706557remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706559remestemcel-L-rknd Kit Patient Weight 62.5 - < 75 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706561remestemcel-L-rknd Kit Patient Weight 75 - < 87.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706563remestemcel-L-rknd Kit Patient Weight 87.5 - < 100 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2700778Ryoncil 25,000,000 CELLS per 3.8 ML InjectionSYa4e0918f-7444-4694-adeb-d38d983456595
2706550Ryoncil Kit Patient Weight < 12.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723917Ryoncil Kit Patient Weight 100 - < 112.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723919Ryoncil Kit Patient Weight 112.5 - < 125 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706552Ryoncil Kit Patient Weight 12.5 - < 25 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723921Ryoncil Kit Patient Weight 125 - < 137.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2723923Ryoncil Kit Patient Weight 137.5 - < 150 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706554Ryoncil Kit Patient Weight 25 - < 37.5 KGSYa4e0918f-7444-4694-adeb-d38d983456595
2706556Ryoncil Kit Patient Weight 37.5 - < 50 KGSYa4e0918f-7444-4694-adeb-d38d983456595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73648-113-03736480113031 KIT in 1 CARTON (73648-113-03) * 1 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC * 1 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC * 1 mL in 1 POUCH * 1 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC1 kit2025-03-17NoNoCurrent