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AURLUMYN ILOPROST 100 ug/mL Injection, Solution, 1 vial — NDC 50633-0340-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AURLUMYN ILOPROST 100 ug/mL Injection, Solution, 1 vial — NDC 50633-340-01 (Billing 50633-0340-01)

by BTG International Inc · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of AURLUMYN ILOPROST 100 ug/mL Injection, Solution from BTG International Inc, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 50633-0340-01
🏷️ FDA NDC (as labeled) 50633-340-01 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 Aug 27, 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 50633-340-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50633 labeler · 340 product · 01 package
Package marketed since
Mar 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5063334001 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50633-340-01
Product NDC 50633-340
11-digit billing NDC 50633034001
NCPDP billing unit ML — per mL (volume)
RxCUI 2680303, 2680309
UNII JED5K35YGL
Application # NDA217933
SPL Set ID 34036fc0-6832-d066-e063-6394a90a18a4
Established class (EPC) Prostacycline
Chemical class Prostaglandins I
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ILOPROST

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

GCN Seq No 085742
GCN 55291
HICL code 026287
Ingredient (HICL) Iloprost Tromethamine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A7
Therapeutic class — intermediate (HIC2) Vasoactive Drugs
HIC3 code A7E
Therapeutic class — specific (HIC3) Vasodilators,Miscellaneous
AHFS code 24:12.92.00
AHFS class Vasodilating Agents, Miscellaneous
FDB label name AURLUMYN 100 MCG/ML VIAL
FDB brand name Aurlumyn
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085742
  • GCN: 55291
  • HICL (First Databank): 026287
  • AHFS class code: 24:12.92.00
  • RxCUI (RxNorm): 2680303
Why two NDCs? The FDA registers this code as 50633-340-01 — 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 → 50633-0340-01. 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 Prostacycline class.

Pharmacologic class Prostacycline
Drug family (ATC) Platelet aggregation inhibitors excl. heparin
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 AURLUMYN 100 MCG/ML VIAL Ingredient Iloprost Tromethamine
📖 What it is MedlinePlus · NLM

Iloprost injection is used to treat severe frostbite. Iloprost is in a class of medications called vasodilating agents. It works by relaxing blood vessels.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Aurlumyn is the brand name for iloprost given by IV infusion. It's approved to treat severe frostbite in adults — specifically to lower the chance that you'll lose a finger or toe...
  • No, you won't take this at home. Aurlumyn is given through an IV drip in a clinical setting — a hospital or infusion center — where your nurses and doctors can keep a close eye on...
  • How is this medication given? Do I take it at home?
  • The most common things people notice are headache, flushing (feeling warm or flushed in the face), a fast heartbeat, nausea, vomiting, and dizziness. These can feel uncomfortable b...
📖 Read our full Iloprost guide →
1
Nutrient depletion considerations

Iloprost may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Iloprost nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50633-0340-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2026-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aurlumyn 100 ug/mLthis 50633-0340-01 BTG 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2024
First FDA approval
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 13, 2024 RLD RS ⏳ ~17.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12409183 — method of use (U-4263)
US 12409184 — drug product
Exclusivity NP
Exclusivity ODE-465
2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 12409183 ↗ Method of use U-4263 Jul 18, 2044
US 12409184 ↗ Drug product — Aug 6, 2041
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductFeb 13, 2027
ODE-465Orphan Drug Exclusivity (7-year)Feb 13, 2031
Common questions
Is there a generic version of AURLUMYN 100 MCG/ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AURLUMYN 100 MCG/ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2044 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 8.1 mg / 1 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 0.242 mg / 1 mL UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerBTG International Inc
Application holderBTG INTERNATIONAL INC
FDA applicationNDA217933 (NDA)
Labeler code50633
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from BTG International Inc labeler code 50633

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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes ( 1.1 ).

1.1Frostbite AURLUMYN is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Initiate intravenous infusion at 0.5 ng/kg/minute and titrate in 0.5 ng/kg/minute increments based on tolerability at intervals of 30 minutes to a maximum of 2 ng/kg/minute ( 2.1 ). Administer as continuous infusion for 6 hours each day up to a maximum of 8 consecutive days ( 2.1 ). Patients with moderate or severe hepatic impairment (Child-Pugh Class B or C): initiate infusion at 0.25 ng/kg/minute and titrate as described above ( 2.3 ).

Patients with renal impairment with eGFR less than 30 mL/min: initiate infusion at 0.5 ng/kg/minute and titrate as described above. If the patient cannot tolerate the starting dose of 0.5 ng/kg/minute, the dose can be decreased to 0.25 ng/kg/minute ( 2.4 ). See Full Prescribing Information for instructions on preparation and administration ( 2.2 ).

2.1Recommended Dosage Monitor vital signs prior to the start of the infusion and with every dose increase. Administer AURLUMYN as a continuous intravenous infusion over 6 hours each day for up to a maximum of 8 consecutive days. Start the initial infusion on day 1 at a rate of 0.5 ng/kg/minute and increase in increments of 0.5 ng/kg/minute every 30 minutes according to tolerability up to 2 ng/kg/minute.

Dosage is based on actual patient body weight (kg). Repeat dose titration steps on day 2 and day 3. From day 4 onward, start the infusion at the highest tolerated dose from the previous day, and adjust the rate as needed, based on tolerability.

Adverse reactions such as headache, flushing, jaw pain, myalgia, nausea, and vomiting may be dose-limiting. If dose-limiting adverse reactions occur that cannot be tolerated by the patient, then decrease the dose in a stepwise manner by 0.5 ng/kg/min every 30 minutes, until a tolerated dose is reached. If a dose-limiting adverse reaction occurs during administration of AURLUMYN at the starting dose, the infusion should be discontinued, and re-initiation of the infusion can be attempted after the event has resolved or been treated.

If infusion is stopped at any point for a dose-limiting adverse event, infusion can be reinitiated at a previously tolerated dose/infusion rate once the event has resolved. The maximum tolerated dose should be maintained for the remaining 6-hour daily infusion.

2.2Preparation and Administration Preparation: Use aseptic technique to prepare AURLUMYN. Inspect the vial for particulate matter prior to administration. Do not use if the solution is discolored or cloudy or if foreign particles are present.

Dilution: AURLUMYN should only be diluted using 0.9% Sodium Chloride Injection, USP. Do not dilute or mix AURLUMYN with any other parenteral medications or solutions prior to or during administration. Withdraw 1 mL (100 mcg) of AURLUMYN solution from the vial and transfer into 100 mL of 0.9% Sodium Chloride Injection, USP polyvinyl chloride (PVC) infusion bag to make a final concentration of 1 mcg/mL (1,000 ng/mL).

AURLUMYN can be added to commercially available infusion bags labeled to contain 100 mL of 0.9% Sodium Chloride Injection, USP. Gently mix the intravenous bag by slowly inverting the bag. Do not shake.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if visibly opaque particles, discoloration, or foreign particles are observed. Immediately use diluted AURLUMYN infusion solution.

If not used immediately, the diluted solution can be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 4 hours. Administration Administer AURLUMYN as an intravenous infusion through a peripheral line or peripherally inserted central catheter using an infusion pump. Use an infusion set with an in-line 0.22- or 0.2-micron filter.

Once diluted, AURLUMYN should be administered with an infusion pump that can support the minimum and maximum flow rates. The infusion pump used to administer AURLUMYN should: (1) be able to deliver rates 0.1 to 99… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mcg per mL iloprost as a clear and colorless solution in a single-dose vial. Injection: 100 mcg per mL in a single dose vial ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 ).

⚠️ Warnings and Cautions 86 words ▾

5 WARNINGS AND PRECAUTIONS AURLUMYN may cause symptomatic hypotension. Monitor vital signs while initiating AURLUMYN. Correct hypotension prior to administration of AURLUMYN ( 5.1 ).

5.1Hypotension AURLUMYN is a systemic vasodilator and may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN.

Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications while administering AURLUMYN to reduce potential additive hypotensive effects. Consider down-titration or discontinuation of AURLUMYN if hypotension persists despite discontinuation of other antihypertensives and fluid resuscitation.

🤒 Adverse Reactions 192 words ▾

6 ADVERSE REACTIONS Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension (6.1). To report SUSPECTED ADVERSE REACTIONS, contact BTG International, Inc. at 1-877-377-3748 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse events reported with the use of intravenous iloprost in patients with frostbite from the published literature include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension. Pre-marketing safety data on AURLUMYN were obtained from 116 patients with Systemic Sclerosis receiving iloprost in 2 multicenter, double-blind, randomized, placebo-controlled studies in patients with Systemic Sclerosis experiencing symptomatic digital ischemic episodes (Raynaud's Phenomenon).

Patients received intravenous AURLUMYN administered as a continuous infusion over 6 hours each day for 5 consecutive days and the dose was adjusted according to individual tolerability within the range of 0.5 to 2.0 ng /kg /min. The observed safety profile in these patients was similar to that observed with IV iloprost.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ).

8.1Pregnancy Risk Summary There are no available data with AURLUMYN during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are limited published cases of inhaled iloprost use during pregnancy, primarily during the second and third trimesters, that have not identified a drug-associated risk of adverse maternal or fetal outcomes. In animal reproductive studies, administration of continuous intravenous iloprost to pregnant Han-Wistar rats during organogenesis at doses 2-times the maximum recommended human dose on a mg/m 2 basis resulted in adverse developmental outcomes.

However, there were no adverse developmental outcomes with oral or intravenous administration of iloprost to pregnant Sprague-Dawley rats, rabbits, and monkeys at doses 1111-, 1061-, and 12-times, respectively, the maximum recommended human dose by Cmax ( see Data ). The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In developmental toxicity studies in pregnant Han-Wistar rats, continuous intravenous administration of iloprost at a dosage of 0.01 mg/kg daily (2 times the maximum recommended human dose on a mg/m 2 basis, serum levels not available) led to shortened digits of the thoracic extremity in fetuses and pups. In similar studies in pregnant Sprague-Dawley rats that received iloprost clathrate (13% iloprost by weight) orally at dosages of up to 50 mg/kg/day (C max of 90 ng/mL), in pregnant rabbits at intravenous dosages of up to 0.5 mg/kg/day (C max of 86 ng/mL), and in pregnant monkeys at dosages of up to 0.04 mg/kg/day (serum levels of 1 ng/mL), at 1111-, 1062- and 12-times, respectively, the maximum recommended human dose by Cmax, no such digital anomalies or other gross-structural abnormalities were observed in the fetuses/pups.

However, in gravid Sprague-Dawley rats, iloprost clathrate (13% iloprost) significantly increased the number of non-viable fetuses at a maternally toxic oral dosage of 250 mg/kg/day (729 times the maximum recommended human dose on a mg/m 2 basis) and in Han-Wistar rats was found to be embryolethal in 15 of 44 litters at an intravenous dosage of 1 mg/kg/day (225 times the maximum recommended human dose on a mg/m 2 basis).

8.2Lactation Risk Summary There are no data on the presence of iloprost in human milk, the effects on the breastfed infant, or the effects on milk production. Iloprost is present in rat milk ( see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

Because of the potential for serious adverse reactions, advise women not to breastfeed during treatment with iloprost [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . Data In studies with Han-Wistar rats, higher mortality was observed in pups of lactating dams receiving iloprost intravenously at 1 mg/kg daily (at 225 times the maximum recommended human dose on a mg/m 2 basis). In Sprague-Dawley rats, higher mortality was also observed in nursing pups at a maternally toxic oral dose of 250 mg/kg/day of iloprost clathrate (13% iloprost by weight) (729 times the maximum recommended human dose on a mg/m 2 basis).

In rats, a passage of low levels of iloprost or metabolites into the milk was observed (less than 1% of iloprost dose given intravenously). No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of iloprost did not include suffici… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data with AURLUMYN during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are limited published cases of inhaled iloprost use during pregnancy, primarily during the second and third trimesters, that have not identified a drug-associated risk of adverse maternal or fetal outcomes. In animal reproductive studies, administration of continuous intravenous iloprost to pregnant Han-Wistar rats during organogenesis at doses 2-times the maximum recommended human dose on a mg/m 2 basis resulted in adverse developmental outcomes.

However, there were no adverse developmental outcomes with oral or intravenous administration of iloprost to pregnant Sprague-Dawley rats, rabbits, and monkeys at doses 1111-, 1061-, and 12-times, respectively, the maximum recommended human dose by Cmax ( see Data ). The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In developmental toxicity studies in pregnant Han-Wistar rats, continuous intravenous administration of iloprost at a dosage of 0.01 mg/kg daily (2 times the maximum recommended human dose on a mg/m 2 basis, serum levels not available) led to shortened digits of the thoracic extremity in fetuses and pups. In similar studies in pregnant Sprague-Dawley rats that received iloprost clathrate (13% iloprost by weight) orally at dosages of up to 50 mg/kg/day (C max of 90 ng/mL), in pregnant rabbits at intravenous dosages of up to 0.5 mg/kg/day (C max of 86 ng/mL), and in pregnant monkeys at dosages of up to 0.04 mg/kg/day (serum levels of 1 ng/mL), at 1111-, 1062- and 12-times, respectively, the maximum recommended human dose by Cmax, no such digital anomalies or other gross-structural abnormalities were observed in the fetuses/pups.

However, in gravid Sprague-Dawley rats, iloprost clathrate (13% iloprost) significantly increased the number of non-viable fetuses at a maternally toxic oral dosage of 250 mg/kg/day (729 times the maximum recommended human dose on a mg/m 2 basis) and in Han-Wistar rats was found to be embryolethal in 15 of 44 litters at an intravenous dosage of 1 mg/kg/day (225 times the maximum recommended human dose on a mg/m 2 basis).

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of iloprost did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience with iloprost has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 35 words ▾

10 OVERDOSAGE Cases of overdose of intravenous iloprost have not been reported. Hypotension, vomiting, and diarrhea are likely. A specific antidote is not known. Interruption of the infusion session, monitoring, and symptomatic measures are recommended.

🧬 Clinical Pharmacology 218 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Iloprost is a synthetic analog of prostacyclin PGI 2 . Iloprost is a vasodilator and inhibits platelet aggregation.

12.3Pharmacokinetics General Iloprost administered intravenously has linear pharmacokinetics over the dose range of 1 to 3 ng/kg/min. The half-life of iloprost is 20 to 30 minutes. Absorption and Distribution Following intravenous infusion, the apparent steady-state volume of distribution was 0.7 to

0.8L/kg in healthy subjects. Iloprost is approximately 60% protein-bound, mainly to albumin, and this ratio is concentration-independent in the range of 30 to 3000 pg/mL. Metabolism and Excretion In vitro studies reveal that cytochrome P450-dependent metabolism plays only a minor role in the biotransformation of iloprost.

Iloprost is metabolized principally via β-oxidation of the carboxyl side chain. The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form. In animal experiments, tetranor-iloprost was pharmacologically inactive.

Clearance in normal subjects was approximately 20 mL/min/kg. A mass-balance study using intravenously and orally administered [ 3 H]-iloprost in healthy subjects (n = 8) showed recovery of 81% of total radioactivity over 14 hours post-dose, with 68% and 12% recoveries in urine and feces, respectively. Drug Interactions Intravenous infusion of iloprost had no effect on the pharmacokinetics of digoxin.

Acetylsalicylic acid did not alter the clearance (pharmacokinetics) of iloprost.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Iloprost is a synthetic analog of prostacyclin PGI 2 . Iloprost is a vasodilator and inhibits platelet aggregation.

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AURLUMYN (iloprost) injection is a clear, colorless sterile solution supplied as 100 mcg per mL single-dose glass vial per carton (NDC 50633-340-01). Unopened vials of AURLUMYN are stable until the date indicated on the package when stored at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . The unopened vial should be kept in the carton and not exposed to direct sunlight.

Do not freeze.

📦 Storage and Handling 56 words ▾

Unopened vials of AURLUMYN are stable until the date indicated on the package when stored at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . The unopened vial should be kept in the carton and not exposed to direct sunlight. Do not freeze.

📋 Description 193 words ▾

11 DESCRIPTION AURLUMYN contains iloprost, a synthetic analog of prostacyclin PGI 2 . The chemical name for iloprost is (5 E )-[3a S ,4 R ,5 R ,6a S )-5-hydroxy-4-[(1 E )-(3 S ,4 RS )-3-hydroxy-4-methyloct-1-en-6-ynyl]-hexahydropentalen-2(1 H )-ylidene]pentanoic acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47.

Iloprost is an oily substance, which is soluble in methanol, ethanol, ethyl acetate, acetone, and pH 7 buffer, sparingly soluble in buffer pH 9, and very slightly soluble in distilled water, buffer pH 3, and buffer pH 5. The molecular formula of iloprost is C 22 H 32 O 4 and its molecular weight is 360.49. The structural formula is shown below: AURLUMYN (iloprost) injection is a clear, colorless, sterile solution formulated for intravenous use.

AURLUMYN is supplied in single-use glass vials containing 1-mL per vial. Each mL of the solution contains 100 mcg (0.1 mg) of iloprost as the active ingredient and the following inactive ingredients: 8.1 mg ethanol, 9 mg sodium chloride, and 0.242 mg tromethamine. Hydrochloric acid and sodium hydroxide is added to adjust pH to 8.3.

The solution contains no preservatives. Chemical Structure

💬 Information for Patients 39 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients that they may have a fall in blood pressure with AURLUMYN, so they may become dizzy during drug administration. They should stand up slowly when they get out of a chair or bed.

🧬 Pharmacokinetics 193 words ▾

12.3Pharmacokinetics General Iloprost administered intravenously has linear pharmacokinetics over the dose range of 1 to 3 ng/kg/min. The half-life of iloprost is 20 to 30 minutes. Absorption and Distribution Following intravenous infusion, the apparent steady-state volume of distribution was 0.7 to

0.8L/kg in healthy subjects. Iloprost is approximately 60% protein-bound, mainly to albumin, and this ratio is concentration-independent in the range of 30 to 3000 pg/mL. Metabolism and Excretion In vitro studies reveal that cytochrome P450-dependent metabolism plays only a minor role in the biotransformation of iloprost.

Iloprost is metabolized principally via β-oxidation of the carboxyl side chain. The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form. In animal experiments, tetranor-iloprost was pharmacologically inactive.

Clearance in normal subjects was approximately 20 mL/min/kg. A mass-balance study using intravenously and orally administered [ 3 H]-iloprost in healthy subjects (n = 8) showed recovery of 81% of total radioactivity over 14 hours post-dose, with 68% and 12% recoveries in urine and feces, respectively. Drug Interactions Intravenous infusion of iloprost had no effect on the pharmacokinetics of digoxin.

Acetylsalicylic acid did not alter the clearance (pharmacokinetics) of iloprost.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Frostbite The efficacy of intravenous (IV) iloprost for the treatment of severe frostbite to reduce the risk of digit amputations is derived from a published open-label, randomized controlled trial that enrolled patients with severe frostbite (Cauchy et al, 2011; Cheguillaume, 2011) Cauchy, E., et al. (2011). A controlled trial of a prostacyclin and rt-PA in the treatment of severe frostbite.

N Engl J Med 364, 189-190; Cheguillaume, B. (2011). Controlled trial of iloprost and iloprost and rt-PA in the treatment of severe frostbite.

Grenoble School of Medicine Thesis. HAL, https://dumas.ccsd.cnrs.fr/dumas-00618697. . Severe frostbite was defined as having at least one digit (finger or toe) with frostbite stage 3 (lesion extending just past the proximal phalanx) or stage 4 (lesion extending proximal to the metacarpal or metatarsal joint).

The trial randomized 47 patients at a single site between 1996 and 2008. At enrollment, all eligible patients (n=47) were treated with rapid rewarming of areas with frostbite, aspirin 250 mg IV, and buflomedil 400 mg IV and then randomized to Groups A, B or C. All patients continued to receive aspirin 250 mg IV daily up to 8 days.

In addition, Group A (n=15) received buflomedil 400 mg IV for up to 8 days, Group B (n=16) received iloprost IV for 6 hours daily for up to 8 days, and Group C (n=16) received recombinant tissue plasminogen activator IV on Day 1 and iloprost IV for 6 hours daily for up to 8 days. The mean age of the study population was 33 years (range: 18-55 years), 94% were men, 96% sustained frostbite during sports activities, 6% had history of smoking, and none had diabetes. At randomization, 70% of the patients had frostbite involving the feet, 62% had frostbite involving the hands, and 32% had frostbite involving both feet and hands.

The primary endpoint was the presence of an anomaly (absence of uptake) in the bone phase of technetium 99m scan performed 7 days after initial clinical presentation of frostbite (BS2 bone scintigraphy anomaly) in at least one finger/toe affected by severe frostbite. The BS2 bone scintigraphy anomaly is expected to predict risk of amputation. On day 7, the presence of BS2 bone scintigraphy anomaly was observed in 60% (9/15), 0% (0/16) and 19% (3/16) of the patients in Groups A, B, and C, respectively.

Compared to Group A, the presence of bone scintigraphy anomaly was significantly lower in Group B (p < 0.001) and Group C (p<0.03), favoring iloprost. Additional follow-up data confirming amputation were obtained for 40/47 patients, which was concordant with the bone scintigraphy results.

🧪 Nonclinical Toxicology 188 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Iloprost was not mutagenic in bacterial and mammalian cells in the presence or absence of extrinsic metabolic activation. Iloprost did not cause chromosomal aberrations in vitro in human lymphocytes and was not clastogenic in vivo in NMRI/SPF mice. There was no evidence of a tumorigenic effect of iloprost clathrate (13% iloprost by weight) in Sprague-Dawley rats dosed orally for up to 8 months at doses of up to 125 mg/kg/day (C max of 45 ng/mL serum, 556 times the C max at maximum recommended human dose), followed by 16 months at 100 mg/kg/day , or in Crl:CD-1 ® (ICR)BR albino mice dosed orally for up to 24 months at doses of up to 125 mg/kg/day (C max of 156 ng/mL serum, 1926 times the Cmax at maximum recommended human dose).

The recommended clinical dosage regimen for iloprost (2 ng/kg/min) affords a serum C max of 0.081 ng/mL. Fertility of males or females was not impaired in Han-Wistar rats at intravenous doses up to 1 mg/kg/day, 225 times the maximum recommended daily dose of Iloprost on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 185 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Iloprost was not mutagenic in bacterial and mammalian cells in the presence or absence of extrinsic metabolic activation. Iloprost did not cause chromosomal aberrations in vitro in human lymphocytes and was not clastogenic in vivo in NMRI/SPF mice. There was no evidence of a tumorigenic effect of iloprost clathrate (13% iloprost by weight) in Sprague-Dawley rats dosed orally for up to 8 months at doses of up to 125 mg/kg/day (C max of 45 ng/mL serum, 556 times the C max at maximum recommended human dose), followed by 16 months at 100 mg/kg/day , or in Crl:CD-1 ® (ICR)BR albino mice dosed orally for up to 24 months at doses of up to 125 mg/kg/day (C max of 156 ng/mL serum, 1926 times the Cmax at maximum recommended human dose).

The recommended clinical dosage regimen for iloprost (2 ng/kg/min) affords a serum C max of 0.081 ng/mL. Fertility of males or females was not impaired in Han-Wistar rats at intravenous doses up to 1 mg/kg/day, 225 times the maximum recommended daily dose of Iloprost on a mg/m 2 basis.

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL - NDC 50633-340-01 - Carton Label Carton Label

PRINCIPAL DISPLAY PANEL - NDC 50633-340-01 - Vial Label Vial Label

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AURLUMYN (this brand).

Top reported reactions

Death77
Dyspnoea71
Condition Aggravated66
Right Ventricular Failure63
Pulmonary Arterial Hypertension59
Hypotension52
Pulmonary Hypertension40

Reporter sex

922 reports

Serious outcomes

Death282
Life-threatening77
Disabling37
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 104 40
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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 BTG International Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BTG International Inc 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.
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.
← 50633-0330-30 · BTG 50633-0910-20 · BTG →
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.