RYONCIL

Product NDC: 73648-111
11-digit product format: 736480111
Labeler code: 73648
Product ID: 73648-111_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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RYONCIL	REMESTEMCEL-L-RKND	Mesoblast	a4e0918f-7444-4694-adeb-d38d98345659	2025-09-11	Warnings, Adverse reactions	Exact identifier application number: BLA125706 ndc (product): 73648-111

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 27 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797544	Internal RxNorm lookup
2700771	Internal RxNorm lookup
2700778	Internal RxNorm lookup
2706549	Internal RxNorm lookup
2706550	Internal RxNorm lookup
2706551	Internal RxNorm lookup
2706552	Internal RxNorm lookup
2706553	Internal RxNorm lookup
2706554	Internal RxNorm lookup
2706555	Internal RxNorm lookup
2706556	Internal RxNorm lookup
2706557	Internal RxNorm lookup
2706558	Internal RxNorm lookup
2706559	Internal RxNorm lookup
2706560	Internal RxNorm lookup
2706561	Internal RxNorm lookup
2706562	Internal RxNorm lookup
2706563	Internal RxNorm lookup
2706564	Internal RxNorm lookup
2723916	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a4e0918f-7444-4694-adeb-d38d98345659	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73648-111-01	RYONCIL	1 in 1 CARTON	KIT	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73648-111-01	EA - Each	73648-111	7feb5c81-8ff4-40ec-b32b-fdc7b4e7f5d5	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73648-111	RYONCIL (REMESTEMCEL-L-RKND) KIT [MESOBLAST]	4	Current NDC, 1 package rows	20250429_a4e0918f-7444-4694-adeb-d38d98345659.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125706	ryoncil	remestemcel-L-rknd	351(a)	Rx	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2706550	{1 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit < 12.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723919	{10 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 112.5 - < 125 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723921	{11 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 125 - < 137.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723923	{12 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 137.5 - < 150 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706552	{2 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 12.5 - < 25 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706554	{3 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 25 - < 37.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706556	{4 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 37.5 - < 50 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706558	{5 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 50 - < 62.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706560	{6 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 62.5 - < 75 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706562	{7 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 75 - < 87.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706564	{8 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 87.5 - < 100 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723917	{9 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]) } Pack [Ryoncil Kit 100 - < 112.5 kg]	BPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706549	{1 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723918	{10 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723920	{11 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723922	{12 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706551	{2 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706553	{3 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706555	{4 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706557	{5 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706559	{6 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706561	{7 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2706563	{8 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
2723916	{9 (3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection) } Pack	GPCK	a4e0918f-7444-4694-adeb-d38d98345659	5
797544	isopropyl alcohol 70 % Medicated Pad	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2700771	remestemcel-L-rknd 25,000,000 CELLS in 3.8 ML Injection	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706549	remestemcel-L-rknd Kit Patient Weight < 12.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723916	remestemcel-L-rknd Kit Patient Weight 100 - < 112.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723918	remestemcel-L-rknd Kit Patient Weight 112.5 - < 125 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706551	remestemcel-L-rknd Kit Patient Weight 12.5 - < 25 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723920	remestemcel-L-rknd Kit Patient Weight 125 - < 137.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723922	remestemcel-L-rknd Kit Patient Weight 137.5 - < 150 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706553	remestemcel-L-rknd Kit Patient Weight 25 - < 37.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706555	remestemcel-L-rknd Kit Patient Weight 37.5 - < 50 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706557	remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706559	remestemcel-L-rknd Kit Patient Weight 62.5 - < 75 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706561	remestemcel-L-rknd Kit Patient Weight 75 - < 87.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706563	remestemcel-L-rknd Kit Patient Weight 87.5 - < 100 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2700778	Ryoncil 25,000,000 CELLS in 3.8 ML Injection	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706550	Ryoncil Kit Patient Weight < 12.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723917	Ryoncil Kit Patient Weight 100 - < 112.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723919	Ryoncil Kit Patient Weight 112.5 - < 125 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706552	Ryoncil Kit Patient Weight 12.5 - < 25 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723921	Ryoncil Kit Patient Weight 125 - < 137.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2723923	Ryoncil Kit Patient Weight 137.5 - < 150 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706554	Ryoncil Kit Patient Weight 25 - < 37.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706556	Ryoncil Kit Patient Weight 37.5 - < 50 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706558	Ryoncil Kit Patient Weight 50 - < 62.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706560	Ryoncil Kit Patient Weight 62.5 - < 75 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706562	Ryoncil Kit Patient Weight 75 - < 87.5 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2706564	Ryoncil Kit Patient Weight 87.5 - < 100 KG	PSN	a4e0918f-7444-4694-adeb-d38d98345659	5
2700778	3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]	SBD	a4e0918f-7444-4694-adeb-d38d98345659	5
2700771	3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection	SCD	a4e0918f-7444-4694-adeb-d38d98345659	5
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	a4e0918f-7444-4694-adeb-d38d98345659	5
2700778	3.8 ML Ryoncil 6680000 CELLS/ML Injection	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
797544	isopropyl alcohol 70 % Medicated Pad	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
797544	isopropyl alcohol 70 % Topical Cloth	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
797544	isopropyl alcohol 70 % Topical Swab	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2700771	remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706549	remestemcel-L-rknd Kit Patient Weight < 12.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723916	remestemcel-L-rknd Kit Patient Weight 100 - < 112.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723918	remestemcel-L-rknd Kit Patient Weight 112.5 - < 125 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706551	remestemcel-L-rknd Kit Patient Weight 12.5 - < 25 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723920	remestemcel-L-rknd Kit Patient Weight 125 - < 137.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723922	remestemcel-L-rknd Kit Patient Weight 137.5 - < 150 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706553	remestemcel-L-rknd Kit Patient Weight 25 - < 37.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706555	remestemcel-L-rknd Kit Patient Weight 37.5 - < 50 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706557	remestemcel-L-rknd Kit Patient Weight 50 - < 62.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706559	remestemcel-L-rknd Kit Patient Weight 62.5 - < 75 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706561	remestemcel-L-rknd Kit Patient Weight 75 - < 87.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706563	remestemcel-L-rknd Kit Patient Weight 87.5 - < 100 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2700778	Ryoncil 25,000,000 CELLS per 3.8 ML Injection	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706550	Ryoncil Kit Patient Weight < 12.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723917	Ryoncil Kit Patient Weight 100 - < 112.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723919	Ryoncil Kit Patient Weight 112.5 - < 125 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706552	Ryoncil Kit Patient Weight 12.5 - < 25 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723921	Ryoncil Kit Patient Weight 125 - < 137.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2723923	Ryoncil Kit Patient Weight 137.5 - < 150 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706554	Ryoncil Kit Patient Weight 25 - < 37.5 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5
2706556	Ryoncil Kit Patient Weight 37.5 - < 50 KG	SY	a4e0918f-7444-4694-adeb-d38d98345659	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73648-111-01	73648011101	1 KIT in 1 CARTON (73648-111-01) * 1 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC * 1 mL in 1 POUCH	1 kit	2025-03-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RYONCIL	Mesoblast \| Mesoblast, Inc. \| LONZA BIOLOGICS TUAS PTE. LTD. \| Integrated Commercialization Solutions, LLC \| WuXi Advanced Therapies Inc.	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	5