Yutrepia treprostinil 53 ug Capsule, 28-count — NDC 72964-012-01 (Billing 72964-0012-01)
This is a package of 28 capsules of Yutrepia treprostinil 53 ug Capsule from Liquidia Technologies, Inc., marketed since May 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72964-012-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72964 labeler · 012 product · 01 package
- Package marketed since
- May 23, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 28 EA per package
- Barcode (UPC-A, from the NDC)
- 3 7296401201 7
- Medicaid fills, this package
- 66 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 087767
- GCN: 57782
- GPI-14 (Medi-Span): 40170080100120
- HICL (First Databank): 023650
- AHFS class code: 24:12.92.00
- RxCUI (RxNorm): 2714659
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Prostacycline Vasodilator class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's designed to help you do more physical activity without getting as winded. It works by relaxing and opening up the blood vessels in your lungs, which reduces the strain on your...
- What exactly is treprostinil inhalation supposed to do for me?
- It's a bit different from a typical rescue inhaler. With Tyvaso inhalation solution, you use a special ultrasonic device — you fill it from an ampule before your first session of t...
- How do I actually use this inhaler — do I just breathe in like a normal puffer?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Treprostinil — tap one for details:
Treprostinil (Inh) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $221.57 | $6,204.00 / 28 capsule |
| Medicare drug plans payPart D · Q2 2026 | $232.44 | $6,508.29 / 28 capsule |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72964-0012-01 You're viewing this Main listing | 7 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE | 2025-05-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Yutrepia 53 ugthis 72964-0012-01 | Liquidia | 28 capsules | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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.
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.
🛈 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.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11712442 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11712442 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11712442 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11712442 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 10898494 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 10898494 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 10898494 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 10898494 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11660304 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11660304 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11660304 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11660304 ↗ | Method of use | U-4200 | May 5, 2037 |
| US 11744836 ↗ | Drug product | — | May 5, 2037 |
| US 11744836 ↗ | Drug product | — | May 5, 2037 |
| US 11744835 ↗ | Drug product | — | May 5, 2037 |
| US 12390475 ↗ | Drug product | — | May 5, 2037 |
| US 12390475 ↗ | Drug product | — | May 5, 2037 |
| US 12390475 ↗ | Drug product | — | May 5, 2037 |
| US 11744836 ↗ | Drug product | — | May 5, 2037 |
| US 11744835 ↗ | Drug product | — | May 5, 2037 |
| US 11744835 ↗ | Drug product | — | May 5, 2037 |
| US 11744836 ↗ | Drug product | — | May 5, 2037 |
| US 12390475 ↗ | Drug product | — | May 5, 2037 |
| US 11744835 ↗ | Drug product | — | May 5, 2037 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | May 23, 2028 |
| NP | New Product | May 23, 2028 |
| NP | New Product | May 23, 2028 |
| NP | New Product | May 23, 2028 |
Is there a generic version of YUTREPIA 53 MCG INHAL CAP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Liquidia Technologies, Inc. labeler code 72964
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). ( 1.1 ) • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). ( 1.2 )
1.1Pulmonary Arterial Hypertension YUTREPIA is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration [see Clinical Studies ( 14 )] .
1.2Pulmonary Hypertension Associated with ILD YUTREPIA is indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%) [see Clinical Studies ( 14.2 )] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • For oral inhalation only. Do not swallow YUTREPIA capsules. Use only with the provided inhaler ( 2 ) • YUTREPIA should be administered 3 to 5 times per day. The contents of each capsule can be inhaled in 2 breaths. ( 2.1 ) • See Dosage and Administration for full instructions on dosing of patients who are treprostinil-naïve or transitioning from treprostinil inhalation solution to YUTREPIA ( 2.1 )
2.1Usual Dosage In Adults YUTREPIA capsules are for oral inhalation only and should be used only with the supplied inhaler. Do not swallow YUTREPIA capsules. YUTREPIA Dosing in treprostinil-naïve patients : In patients naïve to treprostinil, therapy should begin with 26.5 mcg 3 to 5 times per day, in 2 breaths based on patient response.
Dosing in patients transitioning from treprostinil inhalation solution (Tyvaso) : Patients transitioning from treprostinil inhalation solution (Tyvaso), can begin YUTREPIA therapy 3 to 5 times per day, in 2 breaths, using the doses specified below ( Table 1 ): Table 1: YUTREPIA Dosing in Patients Transitioning from Treprostinil Inhalation Solution *Each breath of Tyvaso delivers approximately 6 mcg of treprostinil. Current Tyvaso Dose* YUTREPIA Dose (Number of Breaths) mcg 5 or less breaths 26.5 mcg 6 to 8 breaths 53 mcg 9 to 11 breaths 79.5 mcg 12 to 14 breaths 106 mcg 15 to 17 breaths 132.5 mcg 18 or more breaths 159 mcg In treprostinil-naïve patients and those transitioning from treprostinil inhalation solution, dose increases of 26.5 mcg per dose each week may be implemented, as tolerated.
The target maintenance dosage is 79.5 mcg to 106 mcg, 4 times daily. Doses above 848 mcg per day have not been studied in patients with PAH. If a scheduled dose is missed, resume therapy as soon as possible at the usual dose.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS YUTREPIA inhalation powder contained in capsule available in 4 strengths: • 26.5 mcg: opaque yellow cap and clear body capsule with “LIQUIDIA 26.5” in black radial imprint on capsule cap. • 53 mcg: opaque green cap and clear body capsule with “LIQUIDIA 53” in white radial imprint on capsule cap. • 79.5 mcg: opaque blue cap and clear body capsule with “LIQUIDIA 79.5” in white radial imprint on capsule cap. • 106 mcg: opaque purple cap and clear body capsule with “LIQUIDIA 106” in white radial imprint on capsule cap.
YUTREPIA inhalation powder contained in capsule is available in 4 strengths: 26.5 mcg, 53 mcg, 79.5 mcg, 106 mcg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Treprostinil may cause symptomatic hypotension. ( 5.1 ) • Treprostinil inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) • Dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.1 ) • May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 )
5.1Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with treprostinil may produce symptomatic hypotension.
5.2Risk of Bleeding Treprostinil inhibits platelet aggregation and increases the risk of bleeding.
5.3Effect of Other Drugs on Treprostinil Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .
5.4Bronchospasm Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with YUTREPIA.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions ( 5 ): - Decrease in systemic blood pressure [see Warnings and Precautions ( 5.1 )] . - Bleeding [see Warnings and Precautions ( 5.2 )] . Most common adverse reactions with YUTREPIA (³10%) are cough, headache, throat irritation, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liquidia Technologies, Inc. at 1-888-393-LQDA (5732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials 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. The safety and tolerability of YUTREPIA was evaluated in an open label study (INSPIRE) of 121 patients with PAH (WHO Group 1 and NYHA Functional Class II [80 patients] and Class III [41 patients]) followed for up to 2 months. The most commonly reported adverse reactions included cough, headache, throat irritation, dizziness, which are known side effects of treprostinil inhalation solution.
Table 2 lists the adverse reactions that occurred at a rate of at least 4% of the overall INSPIRE safety population. The adverse reactions in the INSPIRE study were consistent with those observed in previous studies of inhaled treprostinil. Table 2: Adverse Reactions Occurring in ≥ 4% of Patients in the INSPIRE Study *Transition: Patients were on stable doses of treprostinil inhalation solution for at least 3 months prior to enrollment in the study and transitioned to treatment with YUTREPIA. †Add-on: Patients were prostacyclin-naïve and were taking no more than 2 approved oral PAH therapies for at least 3 months at time of enrollment and addition of treatment with YUTREPIA.
Adverse Reaction Transition* N=55 Add-On† N=66 n (%) n (%) Cough 15 (27) 36 (55) Headache 14 (25) 18 (27) Throat Irritation 5 (9) 14 (21) Dizziness 6 (11) 7 (11) Diarrhea 3 (6) 8 (12) Chest Discomfort 5 (9) 5 (8) Nausea 4 (7) 5 (8) Dyspnea 3 (6) 3 (5) Flushing 1 (2) 5 (8) Oropharyngeal Pain 1 (2) 4 (6)
6.2Adverse Reactions Identified in Post-Marketing Experience The following adverse reaction has been identified during the post-approval use of treprostinil inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: • Angioedema
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Effect of Cytochrome P450 Inhibitors and Inducers In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A. Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil increases exposure (both C max and AUC) to treprostinil.
Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see Warnings and Precautions ( 5.3 )] .
7.2Effect of Other Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. These studies did not show a clinically significant effect on the pharmacokinetics of treprostinil. Treprostinil does not affect the pharmacokinetics or pharmacodynamics of warfarin.
The pharmacokinetics of R- and S- warfarin and the INR in healthy subjects given a single 25 mg dose of warfarin were unaffected by continuous subcutaneous infusion of treprostinil at an infusion rate of 10 ng/kg/min.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations ). In animal studies, no adverse reproductive and developmental effects were seen for treprostinil at 3 9 and 3 145 times the human exposure when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg [see Clinical Pharmacology ( 12.3 )] .
The estimated 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 U.S. 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.
Clinical Considerations Disease-associated maternal and embryo-fetal risk Pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. Data Animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. In studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats.
In pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 154 and 1479 times the human exposure, when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg. In pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. The dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 9 and 145 times the human exposure, when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg.
No treprostinil treatment-related effects on labor and delivery were seen in animal studies. Animal reproduction studies are not always predictive of human response.
8.2Lactation Risk Summary There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Placebo-controlled clinical studies of treprostinil inhalation solution did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. The open-label INSPIRE study in PAH patients included 28 patients aged 65 and over in which no age-related differences were noted. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
8.6Patients with Hepatic Insufficiency Plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects with mild-to-moderate hepatic insufficiency. Uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. Treprostinil has not been studied in patients with severe hepatic insufficiency [see Clinical Pharmacology ( 12.3 )] .
8.7Patients with Renal Insufficiency No dose adjustments are required in patients with renal impairment. Treprostinil is not cleared by dialysis [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations ). In animal studies, no adverse reproductive and developmental effects were seen for treprostinil at 3 9 and 3 145 times the human exposure when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg [see Clinical Pharmacology ( 12.3 )] .
The estimated 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 U.S. 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.
Clinical Considerations Disease-associated maternal and embryo-fetal risk Pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. Data Animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. In studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats.
In pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 154 and 1479 times the human exposure, when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg. In pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. The dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 9 and 145 times the human exposure, when based on C max and AUC, respectively, following a single YUTREPIA dose of 79.5 mcg.
No treprostinil treatment-related effects on labor and delivery were seen in animal studies. Animal reproduction studies are not always predictive of human response.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Placebo-controlled clinical studies of treprostinil inhalation solution did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. The open-label INSPIRE study in PAH patients included 28 patients aged 65 and over in which no age-related differences were noted. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE In general, symptoms of overdose with treprostinil include flushing, headache, hypotension, nausea, vomiting, and diarrhea. Provide general supportive care until the symptoms of overdose have resolved.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
12.2Pharmacodynamics In animals, the vasodilatory effects reduce right and left ventricular afterload and increase cardiac output and stroke volume. Other studies have shown that treprostinil causes a dose-related negative inotropic and lusitropic effect. No major effects on cardiac conduction have been observed.
Treprostinil produces vasodilation and tachycardia. Cardiac Electrophysiology In a clinical trial of 240 healthy volunteers, single doses of treprostinil inhalation solution 54 mcg (the target maintenance dose per session) and 84 mcg (supratherapeutic inhalation dose) prolonged the corrected QTc interval by approximately 10 ms. The QTc effect dissipated rapidly as the concentration of treprostinil decreased.
12.3Pharmacokinetics Absorption In healthy volunteer studies, the systemic exposure (AUC and C max ) post-inhalation was shown to be proportional to the YUTREPIA doses administered (25 mcg – 150 mcg). The treprostinil mean C max , mean AUC inf and median T max following a single inhaled target maintenance dose of 79.5 mcg YUTREPIA were 1.48 ng/mL, 1.04 hr.ng/mL and 0.13 hr, respectively. Distribution In vitro treprostinil is 91% bound to human plasma proteins over the 330-10,000 ng/mL concentration range.
Metabolism and Excretion Of subcutaneously administered treprostinil, only 4% is excreted unchanged in urine. Treprostinil is substantially metabolized by the liver, primarily by CYP2C8. Metabolites are excreted in urine (79%) and feces (13%) over 10 days.
Five apparently inactive metabolites were detected in the urine, each accounting for 10‑15% of the dose administered. Four of the metabolites are products of oxidation of the 3-hydroxyloctyl side chain and one is a glucuroconjugated derivative (treprostinil glucuronide). Elimination Following inhaled administration of YUTREPIA, disposition and elimination is monophasic with a half-life of approximately 30 minutes.
Specific Populations Hepatic Insufficiency Plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects presenting with mild-to-moderate hepatic insufficiency. Treprostinil has not been studied in patients with severe hepatic insufficiency [see Use in Specific Populations ( 8.6 )] . Renal Insufficiency In patients with severe renal impairment requiring dialysis (n=8), administration of a single 1 mg dose of orally administered treprostinil pre-and post-dialysis resulted in AUC0-inf that was not significantly altered compared to healthy subjects [see Use in Specific Populations ( 8.7 )] .
🧬 Mechanism of Action ▾
12.1Mechanism of Action The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING YUTREPIA is supplied in a carton consisting of 1 capsule based, dry powder inhaler (referred to as “inhaler”), 28 capsules (7 foil blister cards of 4 capsules each), and 7 single-use cleaning brushes. The individual capsule well is connected by an air channel to a separate blister well containing a desiccant strip. Descriptions of YUTREPIA carton by capsule strength are provided in Table 4 below: Table 4: YUTREPIA Carton Contents by Capsule Strength Capsule Strength (mcg treprostinil) Capsule Description NDC Number
26.5Opaque yellow cap, clear body, imprinted with “LIQUIDIA 26.5” in black ink radially on cap 72964-011-01 53 Opaque green cap, clear body, imprinted with “LIQUIDIA 53” in white ink radially on cap 72964-012-01
79.5Opaque blue cap, clear body, imprinted with “LIQUIDIA 79.5” in white ink radially on cap 72964-013-01 106 Opaque purple cap, clear body, imprinted with “LIQUIDIA 106” in white ink radially on cap 72964-014-01 YUTREPIA inhalation powder capsules should only be delivered using the capsule-based inhaler. The off-white plastic inhaler consists of a blue protective cap marked with YUTREPIA and a base with a mouthpiece, capsule chamber, and two blue push buttons. Discard the inhaler device after 7 days of use or 56 actuations, whichever comes first.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Capsules should remain in the blister to protect them from moisture and light, and each capsule should be removed only when ready to administer a dose. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION YUTREPIA contains treprostinil sodium, a prostacyclin mimetic. The chemical name for tresprostinil sodium is 2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid, sodium salt with the structural formula: Treprostinil sodium has a molecular formula of C 23 H 33 O 5 Na and a molecular weight of 412.49 daltons equivalent to 390.5 daltons of Treprostinil. YUTREPIA inhalation powder contained in a capsule is intended for oral inhalation.
The capsule contains white to off-white powder of treprostinil sodium and the inactive ingredients L-leucine, polysorbate 80, sodium chloride, sodium citrate, and trehalose. Each 5 mg of YUTREPIA inhalation powder contains 26.5 mcg of treprostinil, where 26.5 mcg of treprostinil is equivalent to 28 mcg of treprostinil sodium. The accompanying inhalation device for delivery of YUTREPIA inhalation powder is a disposable plastic device used to inhale the dry powder contained in the HPMC capsule.
The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow and peak inspiratory flow through the inhalation device, which may vary from patient to patient. Under standardized in vitro testing, the inhalation device delivers the following amounts of treprostinil for each of the YUTREPIA inhalation powder capsule strengths: YUTREPIA Inhalation Powder Delivered Dose a Amount of treprostinil delivered from the device mouthpiece under an in vitro flow rate of 99 L/min with a collection time of 1.2 seconds (2 L total volume).
Capsule Strength (treprostinil) Dose Delivered a 26.5 mcg 15.1 mcg 53 mcg 36.0 mcg 79.5 mcg 56.6 mcg 106 mcg 75.7 mcg Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Train patients in the administration process for YUTREPIA, including dosing, inhaler preparation, administration, cleaning, and maintenance, according to the instructions for use [see Instructions for Use ] . To avoid potential interruptions in drug delivery because of equipment malfunction, patients should have access to a back-up.
If a scheduled dose is missed, resume therapy as soon as possible at the usual dose. © Copyright 2025 Liquidia Technologies, Inc. All rights reserved. Distributed by: Liquidia Technologies, Inc.
Morrisville, NC 27560
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption In healthy volunteer studies, the systemic exposure (AUC and C max ) post-inhalation was shown to be proportional to the YUTREPIA doses administered (25 mcg – 150 mcg). The treprostinil mean C max , mean AUC inf and median T max following a single inhaled target maintenance dose of 79.5 mcg YUTREPIA were 1.48 ng/mL, 1.04 hr.ng/mL and 0.13 hr, respectively. Distribution In vitro treprostinil is 91% bound to human plasma proteins over the 330-10,000 ng/mL concentration range.
Metabolism and Excretion Of subcutaneously administered treprostinil, only 4% is excreted unchanged in urine. Treprostinil is substantially metabolized by the liver, primarily by CYP2C8. Metabolites are excreted in urine (79%) and feces (13%) over 10 days.
Five apparently inactive metabolites were detected in the urine, each accounting for 10‑15% of the dose administered. Four of the metabolites are products of oxidation of the 3-hydroxyloctyl side chain and one is a glucuroconjugated derivative (treprostinil glucuronide). Elimination Following inhaled administration of YUTREPIA, disposition and elimination is monophasic with a half-life of approximately 30 minutes.
Specific Populations Hepatic Insufficiency Plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects presenting with mild-to-moderate hepatic insufficiency. Treprostinil has not been studied in patients with severe hepatic insufficiency [see Use in Specific Populations ( 8.6 )] . Renal Insufficiency In patients with severe renal impairment requiring dialysis (n=8), administration of a single 1 mg dose of orally administered treprostinil pre-and post-dialysis resulted in AUC0-inf that was not significantly altered compared to healthy subjects [see Use in Specific Populations ( 8.7 )] .
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In animals, the vasodilatory effects reduce right and left ventricular afterload and increase cardiac output and stroke volume. Other studies have shown that treprostinil causes a dose-related negative inotropic and lusitropic effect. No major effects on cardiac conduction have been observed.
Treprostinil produces vasodilation and tachycardia. Cardiac Electrophysiology In a clinical trial of 240 healthy volunteers, single doses of treprostinil inhalation solution 54 mcg (the target maintenance dose per session) and 84 mcg (supratherapeutic inhalation dose) prolonged the corrected QTc interval by approximately 10 ms. The QTc effect dissipated rapidly as the concentration of treprostinil decreased.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Pulmonary Arterial Hypertension (WHO Group 1) TRIUMPH I was a 12-week, randomized, double-blind, placebo-controlled multi-center study of patients with PAH. The study population included 235 clinically stable patients with pulmonary arterial hypertension (WHO Group 1), nearly all with NYHA Class III (98%) symptoms who were receiving either bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor) for at least three months prior to study initiation. Concomitant therapy also could have included anticoagulants, other vasodilators (e.g., calcium channel blockers), diuretics, oxygen, and digitalis, but not a prostacyclin.
These patients were administered either placebo or treprostinil inhalation solution in four daily treatment sessions with a target dose of 9 breaths (equivalent to 79.5 mcg YUTREPIA) per session over the course of the 12-week study. Patients were predominantly female (82%), had the origin of PAH as idiopathic/heritable (56%), secondary to connective tissue diseases (33%) or secondary to HIV or previous use of anorexigens (12%); bosentan was the concomitant oral medication in 70% of those enrolled, sildenafil in 30%.
The primary efficacy endpoint of the trial was the change in six-minute walk distance (6MWD) relative to baseline at 12 weeks. 6MWD was measured at peak exposure (between 10 and 60 minutes after dosing), and 3‑5 hours after bosentan or 0.5-2 hours after sildenafil. Patients receiving treprostinil inhalation solution had a placebo-corrected median change from baseline in peak 6MWD of 20 meters at Week 12 (p<0.001).
The distribution of these 6MWD changes from baseline at Week 12 were plotted across the range of observed values ( Figure 1 ). 6MWD measured at trough exposure (defined as measurement of 6MWD at least 4 hours after dosing) improved by 14 meters. There were no placebo-controlled 6MWD assessments made after 12 weeks.
Figure 1. Distributions of 6MWD Changes from Baseline at Week 12 during Peak Plasma Concentration of Treprostinil Inhalation Solution The placebo-corrected median treatment effect on 6MWD was estimated (using the Hodges-Lehmann estimator) within various subpopulations defined by age quartile, gender, geographic region of the study site, disease etiology, baseline 6MWD quartile, and type of background therapy ( Figure 2 ). Figure 2.
Placebo-Corrected Median Treatment Effect (Hodges-Lehmann estimate with 95% CI) on 6MWD Change from Baseline at Week 12 During Peak Plasma Concentration of Treprostinil Inhalation Solution for Various Subgroups Figure 1 Figure 2
14.2Pulmonary Hypertension Associated with ILD (WHO Group 3) INCREASE was a 16-week, randomized, double-blind, placebo-controlled, multicenter study that enrolled 326 patients with PH-ILD. Enrolled study patients predominately had etiologies of idiopathic interstitial pneumonia (45%) inclusive of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema (25%), and WHO Group 3 connective tissue disease (22%). The mean baseline 6MWD was 260 meters.
Patients in the INCREASE study were randomized (1:1) to either placebo or treprostinil inhalation solution in four daily treatment sessions with a target dose of 9 breaths (equivalent to 79.5 mcg YUTREPIA) per session and a maximum dose of 12 breaths (equivalent to 106 mcg YUTREPIA) per session over the course of the 16-week study. Approximately 75% of patients randomized to treprostinil inhalation solution titrated up to a dose of 9 breaths, 4 times daily or greater, with 48% of patients randomized to treprostinil inhalation solution reaching a dose of 12 breaths, 4 times daily during the study.
The primary efficacy endpoint was the change in 6MWD measured at peak exposure (between 10 and 60 minutes after dosing) from baseline to Week 16. Patients receiving treprostinil inhalation solution had a placebo-corrected median change from baseline in peak 6MWD of 21 meters at Week 16 (p=0.004) using Hodges-Lehmann esti… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A two-year rat carcinogenicity study was performed with treprostinil inhalation solution at target treprostinil doses of 5.26, 10.6, and 34.1 mcg/kg/day. There was no evidence for carcinogenic potential associated with treprostinil inhalation in rats at systemic exposure levels up to 35 times following a single YUTREPIA dose of 79.5 mcg [see Clinical Pharmacology ( 12.3 )] . In vitro and in vivo genetic toxicology studies did not demonstrate any mutagenic or clastogenic effects of treprostinil.
Treprostinil sodium did not affect fertility or mating performance of male or female rats given continuous subcutaneous (sc) infusions at rates of up to 450 ng treprostinil/kg/min. In this study, males were dosed from 10 weeks prior to mating and through the 2-week mating period. Females were dosed from 2 weeks prior to mating until gestational day 6.
Oral administration of treprostinil diolamine to Tg.rasH2 mice at 0, 5, 10 and 20 mg/kg/day in males and 0, 3, 7.5 and 15 mg/kg/day in females daily for 26 weeks did not significantly increase the incidence of tumors. Treprostinil diolamine was tested in vivo in a rat micronucleus assay and did not induce an increased incidence of micronucleated polychromatic erythrocytes.
13.2Animal Toxicology and/or Pharmacology In a 2-year rat study with treprostinil inhalation at target doses of 5.26, 10.6, and 34.1 mcg/kg/day, there were more deaths (11) in the mid- and high-dose treprostinil groups during the first 9 weeks of the study, compared to 1 in control groups. At the high-dose level, males showed a higher incidence of inflammation in teeth and preputial gland, and females showed high incidences of inflammation and urothelial hyperplasia in the urinary bladder. The exposures in rats at mid- and high-dose levels were about 15 and 35 times, respectively, the clinical exposure following a single YUTREPIA dose of 79.5 mcg [see Clinical Pharmacology ( 12.3 )] .
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A two-year rat carcinogenicity study was performed with treprostinil inhalation solution at target treprostinil doses of 5.26, 10.6, and 34.1 mcg/kg/day. There was no evidence for carcinogenic potential associated with treprostinil inhalation in rats at systemic exposure levels up to 35 times following a single YUTREPIA dose of 79.5 mcg [see Clinical Pharmacology ( 12.3 )] . In vitro and in vivo genetic toxicology studies did not demonstrate any mutagenic or clastogenic effects of treprostinil.
Treprostinil sodium did not affect fertility or mating performance of male or female rats given continuous subcutaneous (sc) infusions at rates of up to 450 ng treprostinil/kg/min. In this study, males were dosed from 10 weeks prior to mating and through the 2-week mating period. Females were dosed from 2 weeks prior to mating until gestational day 6.
Oral administration of treprostinil diolamine to Tg.rasH2 mice at 0, 5, 10 and 20 mg/kg/day in males and 0, 3, 7.5 and 15 mg/kg/day in females daily for 26 weeks did not significantly increase the incidence of tumors. Treprostinil diolamine was tested in vivo in a rat micronucleus assay and did not induce an increased incidence of micronucleated polychromatic erythrocytes.
📖 Instructions for Use ▾
Instructions for Use YUTREPIA TM (you-TREP-ee-uh) (treprostinil) inhalation powder, for oral inhalation This Instructions for Use contains information on how to inhale YUTREPIA TM . Read these Instructions for Use before you start using YUTREPIA and each time you get a refill. There may be new information.
This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to use YUTREPIA the right way before you use it for the first time. Important information you need to know before inhaling YUTREPIA inhalation powder: • Do not swallow YUTREPIA capsules.
YUTREPIA is for inhalation only. • Use YUTREPIA as prescribed by your healthcare provider. • YUTREPIA capsules come in 4 strengths: 26.5 mcg, 53 mcg, 79.5 mcg, and 106 mcg. • If your prescribed dose is more than 106 mcg, you will need to inhale 2 YUTREPIA capsules. See Figure C : Dosing Chart to help you identify the 2 capsules needed for your prescribed dose. Only use the capsule combinations in the Dosing Chart when your prescribed dose is more than 106 mcg. • The capsule must be inhaled within 5 minutes of opening the blister card or the full dose may not be administered.
Read through this instruction sheet prior to the first use of this product. • Always inhale each capsule 2 times to make sure you get your full dose of YUTREPIA. • Do not wash the inhaler. Keep the inhaler dry. • Wash and dry your hands before using YUTREPIA. • If the contents of the capsule comes in contact with your skin or eyes, rinse the area immediately with water. • YUTREPIA capsules should remain in the blister card(s) and each capsule should be removed only when ready to deliver a dose. Storing YUTREPIA • Store YUTREPIA carton in a clean, dry place at room temperature between 68°F to 77°F (20°C to 25°C). • Leave YUTREPIA capsules in blister card to protect from moisture and light . • Throw away the inhaler after 7 days of use or 56 capsules whichever comes first . • Keep YUTREPIA and all medicines out of the reach of children.
Text Illustration Get to know YUTREPIA The YUTREPIA carton contains (See Figure A): • 1 dry powder inhaler (called “inhaler” in these instructions) • 7 Foil blister cards of YUTREPIA capsules (called “capsules” in these instructions) containing 4 capsules each, in one of 4 available strengths • 7 Cleaning brushes (1 for each day) • 1 Desiccant tab within each blister strip to keep the capsule dry and prevent moisture. Throw away the blister strip and the desiccant tab after removing the capsule. Preparing to use YUTREPIA The capsule must be inhaled within 5 minutes of opening the blister card.
Ensure all supplies are gathered and you are familiar with the use of the product prior to opening the card. STEP 1. Gather your supplies. a.
Place your YUTREPIA carton on a clean, dry surface. b. Remove the inhaler and foil blister cards from the carton (See Figure B) . STEP 2.
Select the capsule(s) for your dose. Use the Dosing Chart (See Figure C) to help you identify the capsule(s) needed for your prescribed dose. • If your prescribed dose is more than 106 mcg, you will need to inhale 2 capsules per the Dosing Chart (see Figure C) . • Only load and inhale 1 capsule at a time. • All capsules in a carton are the same strength. If your prescribed dose requires 2 capsules of different strengths, you will need to select your capsules from 2 separate cartons.
IMPORTANT: For doses requiring 2 capsules, only use the capsule combinations presented in the Dosing Chart (See Figure C) . The order for inhaling 2 capsules does not matter, regardless of capsule strength. STEP 3.
Check the inhaler and blister card(s). a. Look at the inhaler and blister card(s) to make sure they are not damaged (See Figure D) . Do not use the inhaler or capsules if they are damaged. b.
Look at the expiration date on the blister cards to make sure it has not passed (See Figure E) . Do not use the ca… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 26.5 mcg Carton 26.5 mcg Carton NDC 72964-011-01 Rx Only 26.5 mcg per capsule Yutrepia™ (treprostinil) inhalation powder For oral inhalation only DO NOT SWALLOW YUTREPIA CAPSULES Contents: • 28 Capsules (7 Foil blister cards of 4 capsules each) • 1 Dry powder inhaler • 7 Single-use cleaning brushes • Instructions for Use Liquidia™ NDC 72964-011-01 Rx Only 26.5 mcg per capsule Yutrepia™ (treprostinil) inhalation powder Read Instructions for Use before each use. Recommended Dosage: See prescribing information.
Do not remove capsules from blister cards until immediately before use. Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
Distributed by: Liquidia Technologies Inc. Morrisville, NC 27560 Liquidia™ Principal Display Panel - 26.5 mcg Carton
PRINCIPAL DISPLAY PANEL – 53 mcg Carton 53 mcg Carton NDC 72964-012-01 Rx Only 53 mcg per capsule Yutrepia™ (treprostinil) inhalation powder For oral inhalation only DO NOT SWALLOW YUTREPIA CAPSULES Contents: • 28 Capsules (7 Foil blister cards of 4 capsules each) • 1 Dry powder inhaler • 7 Single-use cleaning brushes • Instructions for Use Liquidia™ NDC 72964-012-01 Rx Only 53 mcg per capsule Yutrepia™ (treprostinil) inhalation powder Read Instructions for Use before each use. Recommended Dosage: See prescribing information.
Do not remove capsules from blister cards until immediately before use. Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
Distributed by: Liquidia Technologies Inc. Morrisville, NC 27560 Liquidia™ Principal Display Panel - 53 mcg Carton
PRINCIPAL DISPLAY PANEL – 79.5 mcg Carton 79.5 mcg Carton NDC 72964-013-01 Rx Only 79.5 mcg per capsule Yutrepia™ (treprostinil) inhalation powder For oral inhalation only DO NOT SWALLOW YUTREPIA CAPSULES Contents: • 28 Capsules (7 Foil blister cards of 4 capsules each) • 1 Dry powder inhaler • 7 Single-use cleaning brushes • Instructions for Use Liquidia™ NDC 72964-013-01 Rx Only 79.5 mcg per capsule Yutrepia™ (treprostinil) inhalation powder Read Instructions for Use before each use. Recommended Dosage: See prescribing information.
Do not remove capsules from blister cards until immediately before use. Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
Distributed by: Liquidia Technologies Inc. Morrisville, NC 27560 Liquidia™ Principal Display Panel - 79.5 mcg Carton
PRINCIPAL DISPLAY PANEL – 106 mcg Carton 106 mcg Carton NDC 72964-014-01 Rx Only 106 mcg per capsule Yutrepia™ (treprostinil) inhalation powder For oral inhalation only DO NOT SWALLOW YUTREPIA CAPSULES Contents: • 28 Capsules (7 Foil blister cards of 4 capsules each) • 1 Dry powder inhaler • 7 Single-use cleaning brushes • Instructions for Use Liquidia™ NDC 72964-014-01 Rx Only 106 mcg per capsule Yutrepia™ (treprostinil) inhalation powder Read Instructions for Use before each use. Recommended Dosage: See prescribing information.
Do not remove capsules from blister cards until immediately before use. Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
Distributed by: Liquidia Technologies Inc. Morrisville, NC 27560 Liquidia™ Principal Display Panel - 106 mcg Carton
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
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) | — 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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |