Ryoncil Kit
NDC 73648-111
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Ryoncil (remestemcel-l-rknd) is a BLA-approved product labeled by Mesoblast. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 73648-111 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
73648-111
Proprietary Name:
Ryoncil
Non-Proprietary Name: [1]
Remestemcel-l-rknd
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Code:
73648
Product Label ID:
FDA Application Number: [6]
BLA125706
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
03-17-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 73648-111?
The NDC code 73648-111 is assigned by the FDA to the product Ryoncil. It is commonly known by its generic name, remestemcel-l-rknd. This pharmaceutical product is labeled by Mesoblast and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 73648-111-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
RYONCIL is indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2700771 - remestemcel-L-rknd 25,000,000 CELLS in 3.8 ML Injection
- RxCUI: 2700771 - 3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection
- RxCUI: 2700771 - remestemcel-L-rknd 25,000,000 CELLS per 3.8 ML Injection
- RxCUI: 2700778 - Ryoncil 25,000,000 CELLS in 3.8 ML Injection
- RxCUI: 2700778 - 3.8 ML remestemcel-L-rknd 6680000 CELLS/ML Injection [Ryoncil]
* Please review the full disclaimer at the bottom of this page.
Patient Education
Remestemcel-l-rknd Injection
Remestemcel-l-rknd injection is used to treat a certain type of acute graft versus host disease (aGVHD; a life-threatening complication that can happen after a stem-cell transplant). Remestemcel-l-rknd is in a class of medications called cellular therapy. It works by slowing down the immune system and decreasing inflammation.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
