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RYONCIL remestemcel-l-rknd Kit — NDC 73648-0117-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

RYONCIL remestemcel-l-rknd Kit — NDC 73648-117-04 (Billing 73648-0117-04)

by Mesoblast · 1 KIT in 1 CARTON * 4 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 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC * 1 mL in 1 POUCH * 1 VIAL, PLASTIC in 1 C

This is a package of RYONCIL remestemcel-l-rknd Kit from Mesoblast, marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 73648-0117-04
🏷️ FDA NDC (as labeled) 73648-117-04 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 73648-117-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73648 labeler · 117 product · 04 package
Package marketed since
Mar 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7364811704 2
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73648-117-04
Product NDC 73648-117
11-digit billing NDC 73648011704
NCPDP billing unit EA — each (per item)
RxCUI 797544, 2700771, 2700778, 2706549, 2706550, 2706551, 2706552, 2706553,
Application # BLA125706
SPL Set ID a4e0918f-7444-4694-adeb-d38d98345659
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-17
Dosage form KIT
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99393670726422
GCN Seq No 087386
GCN 57284
HICL code 050113
Ingredient (HICL) Remestemcel-L-Rknd
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code ZA
Therapeutic class — intermediate (HIC2) Drugs Having Action On Wide-Spread Tissue (Cont 1)
HIC3 code ZAI
Therapeutic class — specific (HIC3) Mesenchymal Stromal Cell (Msc)
AHFS code 26:04.00.00
AHFS class Cellular Therapy
FDB label name RYONCIL 75 KG-LESS THAN 87.5KG
FDB brand name Ryoncil
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087386
  • GCN: 57284
  • GPI-14 (Medi-Span): 99393670726422
  • HICL (First Databank): 050113
  • AHFS class code: 26:04.00.00
  • RxCUI (RxNorm): 797544
Why two NDCs? The FDA registers this code as 73648-117-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 73648-0117-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RYONCIL 75 KG-LESS THAN 87.5KG Ingredient Remestemcel-L-Rknd
📖 What it is MedlinePlus · NLM

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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ryoncil treats steroid-refractory acute graft versus host disease in children 2 months and older. That means the condition has not gotten better with steroid treatment.
  • It is given by IV infusion in a clinical setting, usually twice a week for 4 weeks. Your team checks how you are doing around day 28 and decides if more treatment is needed. You wi...
  • Infections, fever, bleeding, swelling, belly pain, and high blood pressure were the most common in the study. Serious side effects can happen too, so keep your care team informed a...
  • Tell your team immediately about fever, trouble breathing, or signs of low blood pressure during or after an infusion. These can be signs of a serious allergic reaction. Report sig...
📖 Read our full Remestemcel-L-Rknd guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3402 $203,659.763 / J3402 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)73648-117-04
11-digit billing NDC73648-0117-04
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3402
DescriptorINJECTION, REMESTEMCEL-L-RKND, PER THERAPEUTIC DOSE
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 U, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
73648-0117-04 You're viewing this Main listing 1 KIT in 1 CARTON * 4 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 VIAL, PLASTIC in 1 CARTON / 3.8 mL in 1 VIAL, PLASTIC * 1 mL in 1 POUCH * 1 VIAL, PLASTIC in 1 C 2025-03-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ryoncil 73648-0118-02 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0112-02 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0114-01 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0119-03 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0116-03 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0113-03 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0120-04 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0111-01 Mesoblast 1 kit — — FDA listed —
Ryoncilthis 73648-0117-04 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0121-05 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0122-03 Mesoblast 1 kit — — FDA listed —
Ryoncil 73648-0115-02 Mesoblast 1 kit — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2024
First FDA approval
Dec 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2036. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 18, 2024 ⏳ ~10.2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
ryoncilremestemcel-L-rknd
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2024 2026 2028 2030 2032 2034 2036
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateDec 18, 2036
Common questions
Is there a biosimilar for RYONCIL 75 KG-LESS THAN 87.5KG?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Remestemcel-L-Rknd inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMesoblast
FDA applicationBLA125706 (BLA)
Labeler code73648
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio12 products on file

More NDCs from Mesoblast labeler code 73648

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE 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. RYONCIL is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous use only. For intravenous use only. The recommended dosage of RYONCIL is 2 × 10 6 MSC/kg body weight per intravenous infusion given twice per week for 4 consecutive weeks.

Infusions should be administered at least 3 days apart. Assess response 28 ± 2 days after the first dose and administer further treatment as appropriate as described in the table below. Recommended Treatment Based on Day 28 Response Response Recommendation Complete Response (CR) No further treatment with RYONCIL Partial or Mixed Response Repeat administration of RYONCIL once a week for additional 4 weeks (4 infusions total) No Response Consider alternative treatments Recurrence of GvHD after CR Repeat administration of RYONCIL twice a week for an additional 4 consecutive weeks (8 infusions total)

2.1Recommended Dosage The recommended dosage of RYONCIL is 2 × 10 6 mesenchymal stromal cells (MSC)/kg body weight per intravenous infusion given twice a week for 4 consecutive weeks for a total of 8 infusions. Administer infusions at least 3 days apart. Assess response 28 ± 2 days after the first dose and administer further treatment as appropriate as described in Table 1 based on Day 28 response.

Table 1: Recommended Treatment based on Day 28 Response Response Recommendation Complete Response No further treatment with RYONCIL Partial or Mixed Response Partial response defined as organ improvement of at least one stage without worsening in any other organ, whereas mixed response was defined as improvement of at least one evaluable organ with worsening in another organ as per International Blood and Marrow Transplantation Registry Severity Index Criteria grading system. Repeat administration of RYONCIL once a week for additional 4 weeks (4 infusions total) No Response Consider alternative treatments Recurrence of GvHD after complete response Repeat administration of RYONCIL twice a week for an additional 4 consecutive weeks (8 infusions total)

2.2Preparation and Administration Instructions Receipt and Storage of RYONCIL RYONCIL is shipped directly to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of ≤ -135°C. RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration [see How Supplied/Storage and Handling (16) ] . Preparation RYONCIL and Plasma-Lyte ® A should be prepared following aseptic technique in a Biological Safety Cabinet (BSC).

Spray and wipe down the following materials with 70% alcohol prior to transferring them into the BSC preparation area. All materials should remain in the BSC preparation area unless discarded. Prepare a sterile water bath to a minimum depth of 4 inches and warm to 37°C (± 2°C) at least 30 minutes prior for thawing.

Supplies needed for preparation of RYONCIL and Plasma-Lyte ® A RYONCIL vials Plasma-Lyte ® A Infusion bag Interlink blood bag spikes (2) Interlink threaded lock cannula (1 per syringe) 60 mL luer-lock syringe (1) 5 mL luer-lock syringe (1 per each thawed vial) 18-gauge needle (1 per each thawed vial) Note: Use a 1mL syringe if volume to be removed from vial is less than 1mL Airtight zip seal plastic bag(s) (1 per each vial for thaw) Water bath Alcohol wipes Note: Plasma-Lyte ® A may be substituted by Plasma-Lyte ® 148 (pH 7.4 with no glucose).

Preparation of Plasma-Lyte ® A 1- Insert the Interlink blood bag spike into the Plasma-Lyte ® A bag. 2- Aseptically attach the threaded lock cannula to a 60 mL syringe. 3- Use an alcohol wipe to scrub the membrane of the Plasma-Lyte ® A bag interlink spike injection site.

4- Attach the threaded lock cannula/syringe assembly to the Plasma-Lyte ® A bag to the injection site. 5- Measure and withdraw 40 mL of Plasma-Lyte ® A from the bag Note: DO NOT remove the syringe containing Plasma-Lyte ® A from the Plasma-Lyte ® A bag. Set aside for later use.

Preparation of RYONCIL 1. Prior to RYONCIL thaw, verify that the pre-arranged time for the RYONCIL a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 90 words ▾

3 DOSAGE FORMS AND STRENGTHS RYONCIL is available as a cell suspension for intravenous infusion in a target concentration of

6.68X 10 6 MSCs per mL in 3.8 mL at cryopreservation contained in a 6 mL cryovial. Each 6 mL cryovial contains approximately 25 x 10 6 MSCs. Cryopreserved MSCs are combined with Plasma-Lyte ® A for administration. RYONCIL is available as a cell suspension for intravenous infusion in a target concentration of

6.68X 10 6 MSCs per mL in 3.8 mL contained in a 6 mL cryovial.

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Do not use RYONCIL in patients with known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins. Known hypersensitivity to dimethyl sulfoxide (DMSO) or Porcine and Bovine proteins. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity/Acute Infusion reactions : Monitor for hypersensitivity reactions during infusion and premedicate with corticosteroids and antihistamines. ( 5.1 ) Transmission of Infectious Agents: RYONCIL may transmit infectious agents. ( 5.2 ) Ectopic Tissue Formation: Ectopic tissue formation may occur following treatment with RYONCIL. ( 5.3 )

5.1Hypersensitivity and Acute Infusion Reactions Hypersensitivity reactions including acute infusion reactions have occurred with RYONCIL administration [see Adverse Reactions (6.1) ] . Serious hypersensitivity reactions, including anaphylaxis, may occur due to DMSO and trace amounts of porcine or bovine proteins. Signs and symptoms may include fever, dyspnea, and hypotension during or after RYONCIL infusion.

Premedicate patients with antihistamine and corticosteroids and monitor closely for signs and symptoms of hypersensitivity or acute infusion reactions. If a hypersensitivity or infusion reaction occurs, interrupt RYONCIL infusion. Do not administer RYONCIL in patients who experience serious or life-threatening reactions.

5.2Transmission of Infectious Agents Transmission of infectious disease or agents may occur with RYONCIL administration because it contains cells from human donors and is manufactured using human, porcine and bovine-derived reagents. Donors are screened and tested for Human Immune-deficiency Virus 1 (HIV-1); Human Immune-deficiency Virus 2 (HIV-2); Hepatitis B Virus (HBV); Hepatitis C Virus (HCV); Human T-cell Leukemia-lymphoma Virus 1 (HTLV-1); Human T-cell Leukemia-lymphoma Virus 2 (HTLV-2); West Nile Virus (WNV); Cytomegalovirus (CMV); Epstein-Barr Virus (EBV); and Syphilis ( Treponema pallidum ).

Only screening was performed for Creutzfeldt-Jakob disease (CJD) and communicable disease risks associated with xenotransplantation. RYONCIL cell banks are tested for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. Human and animal-derived reagents are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use.

These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.

5.3Ectopic Tissue Formation Ectopic tissue formation may occur following treatment with RYONCIL due to the ability of human mesenchymal stromal cells to differentiate into mesenchymal lineage cells such as bone, cartilage and fat cells.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥20%) are: viral infectious disorders, bacterial infectious disorders, infection – pathogen unspecified, pyrexia, hemorrhage, edema, abdominal pain and hypertension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Mesoblast at toll-free phone #1-844-889-MESO (6376) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety data described in this section reflect exposure to RYONCIL in 54 patients in Study MSB-GVHD001 for the treatment of SR-aGvHD. Patients received intravenous infusion of RYONCIL at a dosage of 2 x 10 6 MSCs/kg twice a week for four consecutive weeks, for a total of eight infusions.

Patients with partial or mixed response at Day 28 received additional infusions of RYONCIL 2 x 10 6 MSCs/kg once a week for an additional four weeks [see Clinical Studies (14) ] . The median number of doses administered were 10 (range 1 to 16), and the treatment was administered over a median of 43 days (range 1 to 104 days). Serious adverse reactions occurred in 35 patients (65%) including pyrexia (n=5;9%), respiratory failure (n=5;9%), pneumatosis intestinalis (n=4;7%) and staphylococcal bacteremia (n=2;<5%).

Eight patients had discontinuation of RYONCIL treatment due to the following: acute infusion reactions (n=3), hypotension (n=1), gastroenteritis (n=1), and death (n=3). Table 2 summarizes most common adverse reactions that occurred in ≥10% patients in Study MSB-GVHD001. Table 2: Adverse Reactions** Occurring in ≥10% of Patients in Study MSB-GVHD001 (N=54) a Based on National Cancer Institute Adverse Event Common Toxicity Criteria version 4.03 b No grade 4 or 5 adverse reactions occurred in the study *Is a composite that includes multiple related terms **Includes adverse reactions up to 100 days following RYONCIL treatment Adverse Reactions All Grades a n (%) Grade 3 b n (%) Viral infectious disorders* 30 (56) 8 (15) Bacterial infectious disorders* 24 (44) 10 (19) Infections - pathogen unspecified* 22 (41) 8 (15) Pyrexia 19 (35) 2 (4) Hemorrhage* 15 (28) 4 (7) Edema* 12 (22) 1 (2) Abdominal pain 11 (20) 4 (7) Hypertension 11 (20) 3 (6) Vomiting 10 (19) 3 (6) Arrhythmia* 9 (17) 2 (4) Diarrhea 9 (17) 1 (2) Rash* 9 (17) 0 (0) Arthralgia 8 (15) 0 (0) Fungal infectious disorders* 8 (15) 2 (4) Hypotension 8 (15) 2 (4) Cough 7 (13) 0 (0) Respiratory Failure 6 (11) 6 (11) Table 3 presents the most common grade 3 or 4 laboratory abnormalities that worsened from baseline in ≥10% of patients Table 3: Grade 3 or 4 Laboratory Abnormalities that Worsened from Baseline in ≥ 10% of Patients in Study MSB-GVHD001 (N=54) Laboratory Parameter Grade 3 or higher a % a Based on National Cancer Institute Adverse Event Common Toxicity Criteria version

4.03Gamma-glutamyl transferase increased 32 Thrombocytopenia 28 Blood bilirubin increased 11

👥 Use in Specific Populations 211 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data for RYONCIL use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RYONCIL to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if RYONCIL has the potential to be transferred to the fetus.

Therefore, RYONCIL is not recommended for women who are pregnant. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 10-20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of RYONCIL in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RYONCIL and any potential adverse effects on the breastfed infant from RYONCIL or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of RYONCIL for treatment of SR-GvHD have been established in pediatric patients 2 months of age and older. The use of RYONCIL in these age groups is supported by evidence from an adequate and well-controlled trial [see Adverse Reactions (6) and Clinical Studies (14) ] .

🤰 Pregnancy 90 words ▾

8.1Pregnancy Risk Summary There are no available data for RYONCIL use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RYONCIL to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if RYONCIL has the potential to be transferred to the fetus.

Therefore, RYONCIL is not recommended for women who are pregnant. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 10-20%, respectively.

🧒 Pediatric Use 53 words ▾

8.4Pediatric Use The safety and effectiveness of RYONCIL for treatment of SR-GvHD have been established in pediatric patients 2 months of age and older. The use of RYONCIL in these age groups is supported by evidence from an adequate and well-controlled trial [see Adverse Reactions (6) and Clinical Studies (14) ] .

🧬 Clinical Pharmacology 209 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action for RYONCIL is not clear but may be related to immunomodulatory effects. Data from in vitro studies demonstrate that MSCs inhibit T cell activation as measured by proliferation and secretion of pro-inflammatory cytokines. Acute GvHD occurs when alloreactive donor-derived T cells within the donated tissue (graft) trigger an immunological response, and alloreactive donor-derived T cells play a role in mediating the systemic inflammation, cytotoxicity and potential end organ damage associated with aGvHD.

12.2Pharmacodynamics Human pharmacodynamic data were obtained from analysis of blood samples in pediatric subjects with SR-aGvHD (n=40; age range 0.6-17 years) following treatment with RYONCIL at a dose of 2x10 6 cells/kg. At Baseline, elevated levels of tumor necrosis factor receptor type I (TNFR1) and suppressor of tumorigenicity 2 (ST2) were observed consistent with the inflammatory state of aGvHD. Treatment with RYONCIL reduced the levels of TNFR1 and ST2 by 79% and 75%, respectively, at Day 180 as compared to baseline values.

Further, the circulating levels of CD3+CD4+CD25+HLA-DR+ T cells, which represent activated T cells, were reduced by 64% at Day 180 following treatment with RYONCIL as compared to the baseline values.

12.3Pharmacokinetics No studies have been performed to evaluate the pharmacokinetics of RYONCIL.

🧬 Mechanism of Action 80 words ▾

12.1Mechanism of Action The mechanism of action for RYONCIL is not clear but may be related to immunomodulatory effects. Data from in vitro studies demonstrate that MSCs inhibit T cell activation as measured by proliferation and secretion of pro-inflammatory cytokines. Acute GvHD occurs when alloreactive donor-derived T cells within the donated tissue (graft) trigger an immunological response, and alloreactive donor-derived T cells play a role in mediating the systemic inflammation, cytotoxicity and potential end organ damage associated with aGvHD.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RYONCIL is supplied as a sterile, cryopreserved cell suspension of ex-vivo culture-expanded allogeneic bone marrow-derived mesenchymal stromal cells (MSC) in vials. RYONCIL is provided as a customized kit to meet dosing requirements for a single dose for each patient [see Dosage and Administration (2.1) ] , with each kit containing: Cartons containing sufficient RYONCIL for one infusion based on the patient weight (see Table 5 ) Sufficient alcohol wipes for preparation of the RYONCIL infusions.

Kit sizes and National Drug Codes (NDC) are provided in Table 5. Table 5: RYONCIL Kit Sizes Patient weight (kg) Kit contents (single infusion) Number of kits needed for: 4-vial cartons 1-vial cartons Total cartons Number of alcohol wipes NDC Number Initial course 2 nd course Relapse after CR <12.5 0 1 1 1 73648-111-01 8 4 8 12.5-<25 0 2 2 2 73648-112-02 25-<37.5 0 3 3 3 73648-113-03 37.5-<50 1 0 1 4 73648-114-01 50-<62.5 1 1 2 5 73648-115-02 62.5-<75 1 2 3 6 73648-116-03 75-<87.5 1 3 4 7 73648-117-04 87.5-<100 2 0 2 8 73648-118-02 100-<112.5 2 1 3 9 73648-119-03 112.5-<125 2 2 4 10 73648-120-04 125-<137.5 2 3 5 11 73648-121-05 137.5-<150 3 0 3 12 73648-122-03 RYONCIL is shipped to the clinical facility in a liquid nitrogen dry shipper maintained at a temperature of ≤ -135°C.

Storage conditions : RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration. Handling : Restrict preparation and administration of RYONCIL to a medical facility in which the medical personnel are trained in aseptic technique. Disposal: Dispose empty or partially used RYONCIL vials according to the institutional guidelines for disposal of biohazard materials.

Do not save thawed RYONCIL vials for future use.

📋 Description 93 words ▾

11 DESCRIPTION RYONCIL is provided as a frozen cell suspension in a cryogenic vial. The active ingredient in RYONCIL is comprised of culture-expanded mesenchymal stromal cells (MSCs) isolated from the bone marrow of healthy human adult donors. Each cryovial contains nominally 25 x 10 6 MSCs in 3.8 mL (a target concentration 6.68 x 10 6 cells/mL) formulated in Plasma Lyte ® -A (70% v/v), Human Serum Albumin (HSA) Solution (25%) (20% v/v) and Dimethyl sulfoxide (DMSO) (10% v/v).

The product is thawed and combined with Plasma-Lyte ® A prior to intravenous administration.

💬 Information for Patients 168 words ▾

17 PATIENT COUNSELING INFORMATION Discuss the following with patients and/or caregivers. Hypersensitivity and Acute infusion reactions: Inform patients and/or caregivers that hypersensitivity and acute infusion reactions due to the presence of porcine and bovine protein, and DMSO may occur with RYONCIL infusion. Advise patients and/or caregivers to seek immediate medical evaluation if any signs and symptoms of hypersensitivity or acute infusion reactions occur, such as fever, rash or hives, low blood pressure, breathing problems [see Warnings and Precautions (5.1 ] .

Transmission of Infectious Agents: Inform patients and/or caregivers about the possible risk of transmission of infectious agents with RYONCIL administration [see Warnings and Precautions (5.2) ] . Ectopic Tissue Formation: Inform patients and/or caregivers about the possible risk of ectopic tissue formation with RYONCIL administration [see Warnings and Precautions (5.3) ] . Manufactured for: Mesoblast, Inc.

1114 Sixth Avenue, Fourth Floor New York, NY 10036 US License number: 2140 RYONCIL is a registered trademark of Mesoblast. All rights reserved. ©2024 Mesoblast, Inc. All rights Reserved V 3

🧬 Pharmacokinetics 13 words ▾

12.3Pharmacokinetics No studies have been performed to evaluate the pharmacokinetics of RYONCIL.

🧬 Pharmacodynamics 113 words ▾

12.2Pharmacodynamics Human pharmacodynamic data were obtained from analysis of blood samples in pediatric subjects with SR-aGvHD (n=40; age range 0.6-17 years) following treatment with RYONCIL at a dose of 2x10 6 cells/kg. At Baseline, elevated levels of tumor necrosis factor receptor type I (TNFR1) and suppressor of tumorigenicity 2 (ST2) were observed consistent with the inflammatory state of aGvHD. Treatment with RYONCIL reduced the levels of TNFR1 and ST2 by 79% and 75%, respectively, at Day 180 as compared to baseline values.

Further, the circulating levels of CD3+CD4+CD25+HLA-DR+ T cells, which represent activated T cells, were reduced by 64% at Day 180 following treatment with RYONCIL as compared to the baseline values.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of RYONCIL was evaluated in a multicenter, prospective, single-arm study (MSB-GVHD 001; NCT02336230). The study enrolled pediatric patients with SR-GvHD Grade B to D (excluding Grade B skin alone) as per International Blood and Marrow Transplantation Registry Severity Index Criteria (IBMTR) after receiving allogeneic hematopoietic stem cell transplantation (HSCT). SR-aGvHD was defined as aGvHD that progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent.

Patients who received a second line therapy for aGvHD prior to screening were excluded. RYONCIL was administered by intravenous infusion at a dosage of 2 x 10 6 MSCs/kg twice a week for four consecutive weeks, for a total of eight infusions. Patients with partial or mixed response at Day 28 received additional infusions of RYONCIL 2 x 10 6 MSCs/kg once a week for an additional four consecutive weeks.

Patients with complete response at Day 28 who experienced recurrence of aGvHD received infusions of RYONCIL 2 x 10 6 MSCs/kg twice a week for an additional four consecutive weeks. A total of 55 patients were enrolled, and 54 were treated with RYONCIL. Among the treated patients (n=54), the demographic characteristics were as follows: median age was 7 years (range: 7 months to 17 years); 36% were females; 56% were White, 19% reported “other” race, 15% were Black, 6% were Asian, 6% American Indian or Alaska Native, 33% were Hispanic and 65% were non-Hispanic.

Among enrolled patients, hematologic malignancies (67%) and non-malignant diseases (33%) were the underlying reasons for allogenic HSCT. SR-GvHD severity was as follows at baseline: Grade B (11%), Grade C (43%), Grade D (46%). Organ involvement at baseline were as follows: skin alone (26%), lower gastrointestinal tract only (39%), multi-organ involvement (35%).

The median duration of prior corticosteroid treatment at baseline was 8 days (range: 2 to 46 days). The main efficacy outcome measures were Day-28 overall response rate (complete response rate and partial response rate) and the duration of response. The efficacy results are summarized in Table 4.

Table 4: Efficacy Results for Study MSB-GVHD001 Response at Day 28 N=54 CI=confidence interval a Two-sided exact binomial confidence interval at the 95% level b Duration of response was calculated from Day-28 response to either progression (worsening by one stage in any organ without improvement in other organs in comparison to prior response assessment), new systemic therapy for aGvHD or death from any cause. c Complete response was defined as resolution of aGvHD in all involved organs as per IBMTR grading system. d Partial response was defined as organ improvement of at least one stage without worsening of any other organ as per IBMTR grading system.

Overall Response Rate n (%) 95% CI a 38 (70%) 56.4,

82.0Duration b (days) Median (range) 54 (7, 159+) Complete Response Rate c n (%) 95% CI a 16 (30%) 18.0,

43.6Partial Response Rate d n (%) 95% CI a 22 (41%) 27.6,

55.0Overall response rate at Day 28 by baseline disease severity is as follows: Grade B (3/6; 50%), Grade C (16/23; 70%), and Grade D (19/25; 76%). Among the 38 responders, the median time from Day-28 response to either death or need for systemic therapy for aGvHD (non-RYONCIL systemic therapy for aGvHD or increase in the dose of corticosteroids to methylprednisolone 2 mg/kg or equivalent) was 111.5 days (range 9, 182+).

🧪 Nonclinical Toxicology 28 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate the effects of RYONCIL on carcinogenesis, mutagenesis or impairment of fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate the effects of RYONCIL on carcinogenesis, mutagenesis or impairment of fertility.

📄 Recent Major Changes 8 words ▾

How Supplied/Storage and Handling ( 16 ) 09/2025

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL remestemcel-L-rknd Ryoncil ® Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) For intravenous administration after thaw and resuspension See Prescribing Information for directions for use. Store at ≤ -135°C Single–use vial Discard unused portion Manufactured for Mesoblast Inc. Rx only 1 mg vial

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 73648- 154 -01 remestemcel-L-rknd Ryoncil ® Suspension for IV Infusion Allogeneic bone marrow-derived mesenchymal stromal cells Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) Single–use vial. Discard unused portion. For intravenous administration after thaw and resuspension Rx only Sterile. No preservative. 1 vial

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 73648- 154 -04 remestemcel-L-rknd Ryoncil ® Suspension for IV Infusion Allogeneic bone marrow-derived mesenchymal stromal cells Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) Single–use vial. Discard unused portion. For intravenous administration after thaw and resuspension Rx only Sterile. No preservative. 4 vials

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 73648-111-01 remestemcel-L-rknd Ryoncil ® Suspension for IV Infusion Allogeneic bone marrow-derived mesenchymal stromal cells Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) Kit for Patient Weight: <12.5 kg Kit Contents: 1 X single vial carton 1 Alcohol Wipe Single–use vial. Discard unused portion. For intravenous administration after thaw and resuspension Rx only Sterile.

No preservative. See Prescribing Information for directions for use. Complete infusion within 5 HOURS of thawing and resuspension of RYONCIL ® .

Each vial contains a target of 25 x 10 6 cells / 3.8 mL. Cryopreserved in: Human Serum Albumin Solution 20% v/v (containing 5% w/v Human Serum Albumin), Plasma Lyte-A 70 % v/v, dimethyl sulfoxide (DMSO) 10% v/v. Contains known sensitizing substances DMSO or Porcine and Bovine proteins (see Prescribing Information, WARNINGS AND PRECAUTIONS).

Store at ≤- 135°C; vapor phase of liquid nitrogen No U.S. standard of potency. Manufactured for Mesoblast Inc. 1114 Sixth Avenue, Fourth Floor New York, NY 10036 U.S.

License number: 2140 GTIN: XXXXXXXXXXXXXX SN: XXXXXXXXXXXX LOT: XXXXXXX EXP: MMMYYYY PNTC-1154.024 1 vial

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 73648-112-02 remestemcel-L-rknd Ryoncil ® Suspension for IV Infusion Allogeneic bone marrow-derived mesenchymal stromal cells Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) Kit for Patient Weight: 12.5 kg – <25 kg Kit Contents: 2 X single vial cartons 2 Alcohol Wipes Single–use vial. Discard unused portion. For intravenous administration after thaw and resuspension Rx only Sterile.

No preservative. See Prescribing Information for directions for use. Complete infusion within 5 HOURS of thawing and resuspension of RYONCIL ® .

Each vial contains a target of 25 x 10 6 cells / 3.8 mL. Cryopreserved in: Human Serum Albumin Solution 20% v/v (containing 5% w/v Human Serum Albumin), Plasma Lyte-A 70 % v/v, dimethyl sulfoxide (DMSO) 10% v/v. Contains known sensitizing substances DMSO or Porcine and Bovine proteins (see Prescribing Information, WARNINGS AND PRECAUTIONS).

Store at ≤- 135°C; vapor phase of liquid nitrogen No U.S. standard of potency. Manufactured for Mesoblast Inc. 1114 Sixth Avenue, Fourth Floor New York, NY 10036 U.S.

License number: 2140 GTIN: XXXXXXXXXXXXXX SN: XXXXXXXXXXXX LOT: XXXXXXX EXP: MMMYYYY PNTC-1154.025 2 vial

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 73648-113-03 remestemcel-L-rknd Ryoncil ® Suspension for IV Infusion Allogeneic bone marrow-derived mesenchymal stromal cells Target 25 X 10 6 / 3.8mL (6.68 x 10 6 /mL) Kit for Patient Weight: 25 kg – <37.5 kg Kit Contents: 3 X single vial cartons 3 Alcohol Wipes Single–use vial. Discard unused portion. For intravenous administration after thaw and resuspension Rx only Sterile.

No preservative. See Prescribing Information for directions for use. Complete infusion within 5 HOURS of thawing and resuspension of RYONCIL ® .

Each vial contains a target of 2… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Mesoblast. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mesoblast is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3402 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 73648-0116-03 · Mesoblast 73648-0118-02 · Mesoblast →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.