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Xhance fluticasone propionate 93 ug Spray, Metered — NDC 71715-0003-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Xhance fluticasone propionate 93 ug Spray, Metered — NDC 71715-003-31 (Billing 71715-0003-31)

by Paratek Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE

This is a package of Xhance fluticasone propionate 93 ug Spray, Metered from Paratek Pharmaceuticals, Inc., marketed since Jan 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 71715-0003-31
🏷️ FDA NDC (as labeled) 71715-003-31 billing pads the product segment with a zero
This package
Contains120 spray, metered in 1 bottle Pack sizes3 compare ↓
Also priced by: Part D plans $40.85/unit — full pricing hub ↓
Main listing for product 71715-003 · Also comes in: 1 bottle 71715-003-32 1 bottle 71715-003-33
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 71715-003-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71715 labeler · 003 product · 31 package
Package marketed since
Jan 12, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7171500331 1
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Fluticasone Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 14, 2024 — CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex (Golden State Medical Supply Inc.) · FDA recall D-0349-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71715-003-31
Product NDC 71715-003
11-digit billing NDC 71715000331
RxCUI 1946583, 1946589
UNII O2GMZ0LF5W
Application # NDA209022
SPL Set ID 44fcea33-8cfa-3a5c-e063-6394a90aafb2
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-12
Route NASAL
Dosage form SPRAY, METERED
Substance FLUTICASONE PROPIONATE

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

GCN Seq No 077749
GCN 43878
HICL code 007873
Ingredient (HICL) Fluticasone Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7P
Therapeutic class — specific (HIC3) Nasal Anti-Inflammatory Steroids
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name XHANCE 93 MCG NASAL SPRAY
FDB brand name Xhance
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077749
  • GCN: 43878
  • HICL (First Databank): 007873
  • AHFS class code: 48:10.08.00
  • RxCUI (RxNorm): 1946583
Why two NDCs? The FDA registers this code as 71715-003-31 — 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 → 71715-0003-31. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
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 XHANCE 93 MCG NASAL SPRAY Ingredient Fluticasone Propionate
📗 Our plain-language guide HelloPharmacist
  • Xhance is used in adults for chronic rhinosinusitis, which is long-lasting inflammation of the nose and sinuses. It is approved for people with nasal polyps and for those without t...
  • Shake the bottle and prime it before first use. You blow into the mouthpiece while the spray goes into one nostril, then repeat on the other side. Use it regularly, since it works...
  • Steroids like fluticasone do not work right away. Benefit can take 1 to 2 weeks or longer, and everyone responds a little differently.
  • Headache, sore throat, nosebleeds, nasal irritation, nausea, and cough are among the common ones. Call your doctor for repeated nosebleeds, nasal sores, white patches in the nose o...
📖 Read our full Fluticasone Nasal Spray guide →
8
Nutrient depletion considerations

Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluticasone 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 · Q2 2026 $40.85 —
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
71715-0003-31 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE 2026-01-12 — Active
71715-0003-32 71715-003-32 1 BOTTLE in 1 CARTON / 28 SPRAY, METERED in 1 BOTTLE 2026-01-12 — Active
71715-0003-33 71715-003-33 1 BOTTLE in 1 CARTON / 28 SPRAY, METERED in 1 BOTTLE Sample 2026-01-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 120 spray, metered in 1 bottle.
What NDC number is used to bill for this package of Xhance fluticasone propionate 93 ug Spray, Metered?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xhance 93 ug 71143-0375-01 OptiNose 1 bottle $40.837 — Availability likely —
Xhance 93 ugthis 71715-0003-31 Paratek 1 bottle — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2017
First FDA approval
Sep 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 18, 2017 RLD RS ⏳ ~9.4 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 11554229 — method of use (U-2133)
US 12083270 — method of use (U-2133)
US 12616806 — method of use (U-4524)
US 12616806 — method of use (U-4525)
Exclusivity I-940
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035
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 (4)
PatentTypeUse codeExpires
US 11554229 ↗ Method of use U-2133 Feb 23, 2036
US 12083270 ↗ Method of use U-2133 Apr 4, 2031
US 12616806 ↗ Method of use U-4524 Feb 23, 2036
US 12616806 ↗ Method of use U-4525 Feb 23, 2036
FDA exclusivity
CodeWhat it grantsExpires
I-940New indication (3-year)Mar 15, 2027
Common questions
Is there a generic version of XHANCE 93 MCG NASAL SPRAY?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for XHANCE 93 MCG NASAL SPRAY. See the alternatives section for substitutable, lower-cost products.
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerParatek Pharmaceuticals, Inc.
Application holderPARATEK PHARMACEUTICALS INC
FDA applicationNDA209022 (NDA)
Labeler code71715
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Paratek Pharmaceuticals, Inc. labeler code 71715

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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 77 words ▾

1 INDICATIONS AND USAGE XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 )

1.1Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

1.2Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage : 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily. ( 2.1 ) For nasal use only. Shake before use. Prime before initial use. ( 2.2 ) XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. ( 2.2 )

2.1Recommended Dosage The recommended dosage of XHANCE is 186 mcg (1 spray per nostril) or 372 mcg (2 sprays per nostril) twice daily (total daily dose of 372 mcg or 744 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (total daily dose of 744 mcg). Patients should use XHANCE at regular intervals since its effectiveness depends on regular use.

Individual patients will experience a variable time to onset and different degrees of symptom relief. The safety and efficacy of XHANCE when administered in excess of recommended doses have not been established.

2.2Administration Information Shake XHANCE before each use. Administer XHANCE by the nasal route only. Avoid spraying directly on the nasal septum.

Priming Before initial use, prime XHANCE by first gently shaking and then pressing the bottle 7 times or until a fine mist appears. Direct the spray into the air, away from the face. When XHANCE has not been used for ≥ 7 days, prime the pump again by shaking and releasing 2 sprays into the air, away from the face.

Administration Instructions XHANCE is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing (exhaling) into the mouthpiece of the device. To administer XHANCE, insert the tapered tip of the cone-shaped nosepiece deep into one nostril and form a tight seal between the nosepiece and the nostril. Next, place the flexible mouthpiece into the mouth, bending it as necessary to maintain a tight seal with the nostril.

Blow into the mouthpiece, and while continuing to blow, push the bottle up to actuate the spray pump. Continuing to blow through the mouth, but not inhaling or exhaling through the nose, at the time of actuation is important to achieve intended drug deposition. Repeat the process in the other nostril for a full dose [see Instructions for Use ] .

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal spray: Each spray delivers 93 mcg of fluticasone propionate. Nasal spray: 93 mcg of fluticasone propionate in each spray. ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS XHANCE is contraindicated in patients with hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.3 ) and Description ( 11 )] . Hypersensitivity to any ingredient in XHANCE. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Local Nasal Adverse Reactions: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma.

( 5.1 ) Glaucoma and Cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term. ( 5.2 ) Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate.

Discontinue XHANCE if such reactions occur. ( 5.3 ) Immunosuppression and Risk of Infection: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections.

More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.4 ) Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.

( 5.5 ) Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.7 )

5.1Local Nasal Adverse Reactions Epistaxis, Nasal Erosions and Ulcerations In placebo-controlled clinical trials of 16 weeks duration, epistaxis, nasal erosions, and nasal ulcerations were reported more frequently in patients treated with XHANCE than those who received placebo [see Adverse Reactions ( 6.1 )] . Nasal Septal Perforation Nasal septal perforations have been reported in patients following the nasal application of XHANCE. In placebo-controlled clinical trials of 16 weeks duration, nasal septal perforation was reported in 1 (0.3%) patient treated with XHANCE compared with none treated with placebo.

The patient had a prior history of nasal/sinus surgery. Three (0.3%) patients treated with XHANCE in uncontrolled, open-label trials of 3 to 12 months duration developed nasal septal perforations. As with any long term topical treatment of the nasal cavity, patients using XHANCE over several months or longer should be examined periodically for possible changes in the nasal mucosa.

If a septal perforation is noted, discontinue XHANCE. Avoid spraying XHANCE directly on the septum. Candida Infection In clinical trials with XHANCE, localized infections with Candida albicans have been observed.

Eight (0.9%) patients in uncontrolled, open-label trials of 3 to 12 months duration developed Candida albicans infections (nasal, pharyngeal, esophageal or intestinal). If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of XHANCE. Patients using XHANCE should be examined periodically for evidence of Candida infection in the nasal and oropharyngeal mucosa.

Impaired Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should avoid using XHANCE until healing has occurred.

5.2Glaucoma and Cataracts Nasal and inhaled corticosteroids, including fluticasone propionate, may result in the development of glaucoma and/or cataracts. In placebo-controlled clinical trials of 16 weeks duration, cataracts were reported in 4 (1.2%) patients treated with XHANCE, compared with 3 (1.9%) patients treated with placebo. Among these patients, 2 patients treated with XHANCE reported subcapsular cataracts compared with none treated with placebo.

Eleven patients (1.2%) in uncontrolled, open-label trials of 3 to 12 months duration developed new or worsening cataracts, of which none were subcapsular. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions: [see Warnings and Precautions ( 5.1 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Immunosuppression and Risk of Infection [see Warnings and Precautions ( 5.4 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.7 )] Effect on Growth [see Warnings and Precautions ( 5.8 )] CRSwNP: The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

( 6.1 ) CRSsNP: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-678-6673 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chronic Rhinosinusitis with Nasal Polyps The safety data described below are based on two placebo-controlled clinical trials evaluating doses of a fluticasone propionate nasal spray with an exhalation delivery system from 93 mcg twice daily to 372 mcg twice daily.

Both trials were 16-weeks in duration with an additional 8-week open-label extension. The trials included a total of 643 adult patients with bilateral nasal polyps and associated moderate or severe nasal congestion of which 161 received 93 mcg twice daily, 160 received 186 mcg twice daily, 161 received 372 mcg twice daily and 161 received placebo. The overall pooled safety data included 296 (46.0%) Female, 347 (54.0%) Male, 584 (90.8%) White, 39 (6.1%) Black, 9 (1.4%) Asian, and 11 (1.7%) patients classified as Other.

Of these patients, 45 (7%) were 65 years of age or older. Table 1 displays adverse reactions with an incidence of ≥ 3% in the XHANCE 186 mcg and 372 mcg twice daily patients, and more common than placebo. Table 1.

Summary of Adverse Reactions with XHANCE Reported in ≥ 3% of Patients with CRSwNP and More Common Than Placebo in Placebo-Controlled Studies XHANCE Adverse Reaction Placebo (N = 161) n (%) 186 mcg bid* (N = 160) n (%) 372 mcg bid^ (N = 161) n (%) *186 mcg bid = 1 spray per nostril twice daily ^372 mcg bid = 2 sprays per nostril twice daily 1 Includes spontaneous adverse reaction reports 2 Include ulcerations and erosions Epistaxis 1 4 (2.5) 19 (11.9) 16 (9.9) Nasopharyngitis 8 (5.0) 3 (1.9) 12 (7.5) Nasal septal ulceration 2 3 (1.9) 11 (6.9) 12 (7.5) Nasal congestion 6 (3.7) 7 (4.4) 9 (5.6) Acute sinusitis 6 (3.7) 7 (4.4) 8 (5.0) Headache 5 (3.1) 8 (5.0) 6 (3.7) Pharyngitis 2 (1.2) 2 (1.3) 5 (3.1) Nasal mucosal ulceration 2 2 (1.3) 6 (3.8) 4 (2.5) Nasal mucosal erythema 6 (3.7) 9 (5.6) 8 (5.0) Nasal septal erythema 3 (1.9) 6 (3.8) 7 (4.3) Other adverse reactions with XHANCE observed with an incidence < 3% but ≥ 1% and more common than placebo included: nasal dryness, sinusitis, oropharyngeal pain, toothache, intraocular pressure increase, dizziness, abdominal discomfort, and weight increase.

5.0% of patients treated with XHANCE 186 mcg twice daily and 1.2% of patients treated with 372 mcg twice daily discontinued from the clinical trials prior to the open-label extension because of adverse reactions compared to 4.3% of patients treated with placebo. There were no clinically relevant differences in the incidence of adverse reactions based on gender. Clinical trials did not include sufficient numbers of non-C… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 190 words ▾

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )

7.1Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur. Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology ( 12.3 )] .

During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole Coadministration of orally inhaled fluticasone propionate (1000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor patients for signs of increased drug exposure. ( 8.6 )

8.1Pregnancy Risk Summary Available data from published literature on the use of inhaled or nasal fluticasone propionate in pregnant women have not reported a clear association with adverse developmental outcomes. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis.

However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis ( see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species.

Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately 0.4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 45 mcg/kg/day).

The mouse NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.34 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity.

The NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 5.5 mcg/kg/day). In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.02 times the MRHDID and higher (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day).

The NOAEL was observed in rabbit fetuses with a dose approximately 0.002 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published literature on the use of inhaled or nasal fluticasone propionate in pregnant women have not reported a clear association with adverse developmental outcomes. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight, and/or skeletal variations in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis.

However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis ( see Data ). Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species.

Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately 0.4 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.3 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 45 mcg/kg/day).

The mouse NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.34 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity.

The NOAEL was observed with a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal inhalation dose of 5.5 mcg/kg/day). In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.02 times the MRHDID and higher (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose approximately 0.1 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 4 mcg/kg/day).

The NOAEL was observed in rabbit fetuses with a dose approximately 0.002 times the MRHDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 0.7 times the MRHDID (on… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of XHANCE in pediatric patients have not been established. Effects on Growth Controlled clinical trials have shown that nasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.

The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving nasal corticosteroids should be monitored routinely (e.g., via stadiometry).

The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. Controlled clinical trials have shown that corticosteroids orally inhaled into the lungs may cause a reduction in growth in pediatric patients. In these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appeared to depend upon dose and duration of exposure.

The effects on growth velocity of treatment with corticosteroids orally inhaled into the lungs for over 1 year, including the impact on final adult height, are unknown. The growth of children and adolescents receiving corticosteroids should be monitored routinely (e.g., via stadiometry) [see Warnings and Precautions ( 5.8 )] .

🧓 Geriatric Use 137 words ▾

8.5Geriatric Use Clinical trials of XHANCE for Chronic Rhinosinusitis with Nasal Polyps did not include sufficient numbers of patients aged 65 years and older to determine whether they responded differently than younger patients. Other reported clinical experience with fluticasone administered nasally or orally inhaled has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. There were 82 patients 65 years of age and older in clinical trials for Chronic Rhinosinusitis without Nasal Polyps [see Clinical Studies ( 14 )] .

Of the total number of XHANCE-treated patients in these studies, 51 (14%) were 65 years of age and older. No overall differences in safety and effectiveness of XHANCE have been observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 17 words ▾

10 OVERDOSAGE Overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.5 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.

The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects CRSsNP and CRSwNP and associated inflammatory symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

The anti-inflammatory action of corticosteroids contributes to their efficacy. In 7 trials in adults, fluticasone propionate nasal spray decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). In addition, studies suggest that carbon dioxide, which is present in the exhaled breath delivered into the nose through the device, may influence inflammatory mediator activity and neuropeptide activity, possibly through mechanisms of action that also include removal of nitric oxide, change in pH, or positive pressure.

The direct relationship of these findings to long-term symptom relief is not known.

12.2Pharmacodynamics HPA Axis Effect The potential systemic effects of XHANCE on the HPA axis have not been evaluated. Serum cortisol concentrations, urinary excretion of cortisol, and urine 6-β- hydroxycortisol excretion collected over 24 hours in 24 healthy subjects following 8 oral inhalations of fluticasone propionate 44, 110, and 220 mcg decreased with increasing dose. However, in patients with asthma treated with 2 oral inhalations of fluticasone propionate 44, 110, and 220 mcg twice daily for at least 4 weeks, differences in serum cortisol AUC 0-12h (n = 65) and 24-hour urinary excretion of cortisol (n = 47) compared with placebo were not related to dose and generally not significant.

The potential systemic effects of orally inhaled fluticasone propionate on the HPA axis were also studied in subjects with asthma [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6 )] . Fluticasone propionate given by oral inhalation aerosol at dosages of 440 or 880 mcg twice daily was compared with placebo in oral corticosteroid‑dependent subjects with asthma (range of mean dose of prednisone at baseline: 13 to 14 mg/day) in a 16-week trial. Consistent with maintenance treatment with oral corticosteroids, abnormal plasma cortisol responses to short cosyntropin stimulation (peak plasma cortisol less than 18 mcg/dL) were present at baseline in the majority of subjects participating in this trial (69% of subjects later randomized to placebo and 72% to 78% of subjects later randomized to fluticasone propionate HFA).

At week 16, 8 subjects (73%) on placebo compared with 14 (54%) and 13 (68%) subjects receiving fluticasone propionate HFA (440 and 880 mcg twice daily, respectively) had poststimulation cortisol levels of less than 18 mcg/dL. Cardiac Electrophysiology A study specifically designed to evaluate the effect of XHANCE on the QT interval has not been conducted.

12.3Pharmacokinetics The activity of XHANCE is due to the parent drug, fluticasone propionate. Due to the low bioavailability by the nasal route, the majority of the pharmacokinetic data were obtained via other routes of administration. Absorption The mean (SD) peak exposure (C max ) and total exposure (AUC 0-∞ ) following administration of a dose of 186 mcg of XHANCE during exhalation were 17.2 ± 7.40 pg/mL and 111.7 ± 49.75 pg·h/mL, res… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.

The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects CRSsNP and CRSwNP and associated inflammatory symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

The anti-inflammatory action of corticosteroids contributes to their efficacy. In 7 trials in adults, fluticasone propionate nasal spray decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). In addition, studies suggest that carbon dioxide, which is present in the exhaled breath delivered into the nose through the device, may influence inflammatory mediator activity and neuropeptide activity, possibly through mechanisms of action that also include removal of nitric oxide, change in pH, or positive pressure.

The direct relationship of these findings to long-term symptom relief is not known.

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

16 HOW SUPPLIED/STORAGE AND HANDLING XHANCE (fluticasone propionate) nasal spray is supplied as a non-removable amber glass bottle fitted with a metered-dose manual spray pump unit inside the white XHANCE device with a nasal applicator, valve mechanism, asymmetrical cone-shaped nosepiece, flexible mouthpiece, base, and orange cap in a box of 1. Each metered spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone shaped nosepiece. They are supplied as follows: One (1) bottle net fill content of 16 mL that, after priming, will provide 120 metered sprays (NDC 71715-003-31) with FDA approved Patient Labeling [see Instructions for Use ].

The bottle should be discarded after 120 metered sprays even though the bottle is not empty. Beyond 120 metered sprays, the correct amount of medication in each metered spray cannot be assured. One (1) bottle net fill content of 6.4 mL that, after priming, will provide 28 metered sprays (NDC 71715-003-32) with FDA approved Patient Labeling [see Instructions for Use ].

The bottle should be discarded after 28 metered sprays even though the bottle is not empty. Beyond 28 metered sprays, the correct amount of medication in each metered spray cannot be assured. Store at room temperature (between 15°C and 25°C; 59°F and 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).

Avoid exposure to extreme heat, cold or light. Shake XHANCE before each use.

📋 Description ~1 min read ▾

11 DESCRIPTION The active component of XHANCE is fluticasone propionate, a corticosteroid, having the chemical name S -(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17β-carbothioate, 17‑propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.57, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and dichloromethane, and slightly soluble in 96% ethanol.

XHANCE (fluticasone propionate) nasal spray, 93 mcg, for nasal administration, with an exhalation delivery system that delivers an aqueous suspension of microfine fluticasone propionate having a particle size distribution in the range of 0 to 5 microns for topical nasal administration by means of a metering, atomizing spray pump and exhaled breath. XHANCE also contains benzalkonium chloride, carboxymethylcellulose sodium, dextrose, edetate disodium dihydrate, microcrystalline cellulose, polysorbate 80, purified water, and sodium hydroxide and hydrochloric acid (to adjust pH), and has a pH between 5 and 7.

Before initial use, prime XHANCE by gently shaking and then pressing the amber glass bottle 7 times or until a fine mist appears. When XHANCE has not been used for ≥ 7 days, prime again by releasing 2 sprays into the air, away from the face [see Dosage and Administration ( 2.2 ) and Instructions for Use ] . After priming, each spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone-shaped nosepiece.

The system also has a flexible mouthpiece. Within the device is a non‑removable amber glass bottle with a metering spray pump, an applicator, and a valve that prevents release of breath until the bottle is pressed. A base covers the bottom of the bottle, and a removable orange cap covers both the nosepiece and mouthpiece.

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Local Nasal Adverse Reactions Inform patients that treatment with XHANCE may lead to adverse reactions, which include epistaxis, nasal erosions, and nasal ulceration. Candida infection may also occur with treatment with XHANCE.

In addition, XHANCE has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should not use XHANCE until healing has occurred [see Warnings and Precautions ( 5.1 )] . Glaucoma and Cataracts Inform patients that glaucoma and cataracts are associated with long-term use of nasal and orally inhaled corticosteroids, including fluticasone propionate, and may increase the risk of some eye problems.

Consider regular eye exams. Advise patients to notify their healthcare providers if a change in vision is noted while using XHANCE [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions, Including Anaphylaxis Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, rash, bronchospasm, and hypotension, may occur after administration of fluticasone.

If such reactions occur during use with XHANCE, patients should discontinue use of the product [see Warnings and Precautions ( 5.3 )] . Immunosuppression and Risk of Infection Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles, and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions ( 5.4 )] .

Hypercorticism and Adrenal Suppression Advise patients that XHANCE may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to XHANCE [see Warnings and Precautions ( 5.5 )] .

Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased bone mineral density that the use of corticosteroids may pose an additional risk [see Warnings and Precautions ( 5.7 )] . Reduced Growth Velocity The safety and effectiveness of XHANCE use in pediatric patients has not been established. Inform patients that corticosteroids administered by oral inhalation into the lungs or nasally may cause a reduction in growth velocity when administered to pediatric patients [see Warnings and Precautions ( 5.8 )] .

Use Twice Daily for Best Effect Inform patients that they should use XHANCE on a regular basis as directed. XHANCE, like other corticosteroids, does not have an immediate effect on CRSsNP or CRSwNP or symptoms. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for up to 16 weeks or longer.

Maximum benefit may not be reached for a period of months. Patients should not increase the prescribed dosage, but should contact their healthcare providers if symptoms do not improve or if the condition worsens. If a patient missed a dose, the patient should be advised to take the dose as soon as they remember.

The patient should not take more than the recommended dose for the day. Keep Spray Out of Eyes and Mouth Inform patients to avoid spraying XHANCE in their eyes and mouth. How to Use XHANCE It is important for patients to understand how to correctly administer XHANCE nasal spray using the exhalation delivery system.

Advise the patient to carefully read the patient Instructions for Use . Any questions regarding use that the patient has should be directed to the ph… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The activity of XHANCE is due to the parent drug, fluticasone propionate. Due to the low bioavailability by the nasal route, the majority of the pharmacokinetic data were obtained via other routes of administration. Absorption The mean (SD) peak exposure (C max ) and total exposure (AUC 0-∞ ) following administration of a dose of 186 mcg of XHANCE during exhalation were 17.2 ± 7.40 pg/mL and 111.7 ± 49.75 pg·h/mL, respectively, and were 25.3 ± 10.34 pg/mL and 171.7 ± 85.55 pg·h/mL, respectively, following a dose of 372 mcg of XHANCE in healthy subjects.

The C max and AUC 0-∞ following a dose of 372 mcg of XHANCE in patients with mild to moderate asthma were 28.7±18.72 pg/mL and 222.6±84.60 pg·h/mL, respectively. Distribution Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged

4.2L/kg. The percentage of fluticasone propionate bound to human plasma proteins averaged 99%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.

Local exposure within the nasal cavity with XHANCE will differ when used without exhalation through the device. Elimination Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.8 hours. The total blood clearance of fluticasone propionate is high (average: 1093 mL/min), with renal clearance accounting for less than 0.02% of the total.

Metabolism : The only circulating metabolite detected in man is the 17β-carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway. This metabolite had less affinity (approximately 1/2000) than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.

Excretion : Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites. Specific Populations XHANCE was not studied in any special populations, and no gender-specific pharmacokinetic data have been obtained. Pediatric Patients : XHANCE was not studied in pediatric patients, and no pediatric-specific pharmacokinetic data have been obtained with the product.

Patients with Hepatic and Renal Impairment : Formal pharmacokinetic studies using XHANCE have not been conducted in patients with hepatic or renal impairment. However, since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Therefore, patients with hepatic disease should be closely monitored.

Racial or Ethnic Groups : No significant difference in clearance (CL/F) of fluticasone propionate in Caucasian, African-American, Asian, or Hispanic populations has been observed. Drug Interaction Studies Inhibitors of Cytochrome P450 3A4 Ritonavir : Fluticasone propionate is a substrate of CYP3A4. Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor, ritonavir, is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects.

Fluticasone propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with ritonavir (100 mg twice daily). Plasma fluticasone propionate concentrations following fluticasone propionate aqueous nasal spray alone were undetectable (< 10 pg/mL) in most subjects, and when concentrations were detectable, peak levels (C max ) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL) and AUC 0-τ averaged 8.43 pg·h/mL (range: 4.2 to 18.8 pg·h/mL). Fluticasone propionate C max and AUC 0-τ increased to 318 pg/mL (range: 110 to 648 pg/mL) and 3102.6 pg·h/… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics HPA Axis Effect The potential systemic effects of XHANCE on the HPA axis have not been evaluated. Serum cortisol concentrations, urinary excretion of cortisol, and urine 6-β- hydroxycortisol excretion collected over 24 hours in 24 healthy subjects following 8 oral inhalations of fluticasone propionate 44, 110, and 220 mcg decreased with increasing dose. However, in patients with asthma treated with 2 oral inhalations of fluticasone propionate 44, 110, and 220 mcg twice daily for at least 4 weeks, differences in serum cortisol AUC 0-12h (n = 65) and 24-hour urinary excretion of cortisol (n = 47) compared with placebo were not related to dose and generally not significant.

The potential systemic effects of orally inhaled fluticasone propionate on the HPA axis were also studied in subjects with asthma [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6 )] . Fluticasone propionate given by oral inhalation aerosol at dosages of 440 or 880 mcg twice daily was compared with placebo in oral corticosteroid‑dependent subjects with asthma (range of mean dose of prednisone at baseline: 13 to 14 mg/day) in a 16-week trial. Consistent with maintenance treatment with oral corticosteroids, abnormal plasma cortisol responses to short cosyntropin stimulation (peak plasma cortisol less than 18 mcg/dL) were present at baseline in the majority of subjects participating in this trial (69% of subjects later randomized to placebo and 72% to 78% of subjects later randomized to fluticasone propionate HFA).

At week 16, 8 subjects (73%) on placebo compared with 14 (54%) and 13 (68%) subjects receiving fluticasone propionate HFA (440 and 880 mcg twice daily, respectively) had poststimulation cortisol levels of less than 18 mcg/dL. Cardiac Electrophysiology A study specifically designed to evaluate the effect of XHANCE on the QT interval has not been conducted.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Chronic Rhinosinusitis with Nasal Polyps The efficacy of XHANCE was evaluated in two randomized, double-blind, parallel‑group, multicenter, placebo-controlled, dose-ranging trials in adults 18 years and older with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and associated moderate to severe nasal congestion (Trial 1 [NCT01622569], Trial 2 [NCT01624662]). The two trials included a total of 646 patients [348 (53.9%) males and 298 (46.1%) females] with a mean age of 45.5 years. Patients were randomized 1:1:1:1 to receive 93 mcg, 186 mcg, or 372 mcg twice daily or placebo for a period of 16 weeks.

At baseline 35.7%, 79.0%, and 18.3% had polyps graded as mild, moderate, or severe, respectively. In addition, 90.6% of patients reported previous use of a topical steroid nasal spray for the treatment of CRSwNP and 53.6% reported previous sinus surgery or polypectomy. The co-primary efficacy endpoints were 1) change from baseline to Week 4 in nasal congestion / obstruction averaged over the preceding 7 days of treatment and 2) change from baseline to Week 16 in bilateral polyp grade.

Nasal congestion was rated by the patient on a 0 to 3 categorical severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at the time immediately prior to the next dose (instantaneous). Polyp grade was determined by the clinician using nasal endoscopy. Polyps on each side of the nose were graded on a categorical scale (0 = No polyps; 1 = Mild – polyps not reaching below the inferior border of the middle turbinate; 2 = Moderate – polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; 3 = Severe – large polyps reaching below the lower inferior border of the inferior turbinate).

Efficacy was demonstrated for both XHANCE 186-mcg twice daily and XHANCE 372-mcg twice daily (Table 3). Table 3: Effect of XHANCE nasal spray in two randomized, placebo-controlled trials in patients with CRSwNP. bid= twice daily Placebo XHANCE 186-mcg bid XHANCE 372-mcg bid Diff. (95% CI) XHANCE 186-mcg bid vs placebo Diff.

(95% CI) XHANCE 372-mcg bid vs placebo Trial 1 (N) 82 80 79 Baseline nasal congestion 2.31 2.24

2.29LS mean change from baseline in nasal congestion at week 4 -0.24 -0.54 -0.62 -0.30 (-0.48, -0.11) -0.38 (-0.57, -0.19) Baseline total bilateral polyp grade 3.8 3.9

3.7LS mean change from baseline in total bilateral polyp grade at week 16 -0.45 -1.03 -1.06 -0.59 (-0.93, -0.24) -0.62 (-0.96, -0.27) Trial 2 (N) 79 80 82 Baseline nasal congestion 2.29 2.20

2.25LS mean change from baseline in nasal congestion at week 4 -0.24 -0.68 -0.62 -0.45 (-0.64, -0.25) -0.38 (-0.58, -0.18) Baseline total bilateral polyp grade 3.8 3.9

3.9LS mean change from baseline in total bilateral polyp grade at week 16 -0.61 -1.22 -1.41 -0.60 (-0.89, -0.31) -0.80 (-1.08, -0.51) There were no clinically relevant differences in effectiveness of XHANCE across subgroups of patients defined by gender, age, or race. Onset of action, evaluated by determining the starting period that the treatment effect of XHANCE on daily instantaneous AM congestion score started to achieve statistical significance in comparison to placebo and roughly maintained thereafter, was generally observed within 2 weeks for both XHANCE doses.

14.2Chronic Rhinosinusitis without Nasal Polyps The efficacy of XHANCE for Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) was evaluated in two 24-week randomized, double-blind, parallel-group, multicenter, placebo-controlled trials in 555 adults 18 years and older (Trial 3 [NCT03960580] and Trial 4 [NCT03781804]). Trial 3 included 223 patients with CRSsNP and Trial 4 included 332 patients with either CRSsNP (N=124) or CRSwNP (N=208). While Trial 4 included CRSwNP patients, efficacy results from Trials 3 and 4 are presented for CRSsNP patients only.

In both trials, patients were randomized 1:1:1 to receive XHANCE 186 mcg twice daily, XHANCE 372 mcg twice daily, or placebo, all admin… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 129 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1000 mcg/kg (approximately 7 times the MRHDID for adults on a mcg/m 2 basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately equivalent to the MRHDID for adults on a mcg/m 2 basis) for 104 weeks. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test.

Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 0.7 times the MRHDID for adults on a mcg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 126 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1000 mcg/kg (approximately 7 times the MRHDID for adults on a mcg/m 2 basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately equivalent to the MRHDID for adults on a mcg/m 2 basis) for 104 weeks. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test.

Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 0.7 times the MRHDID for adults on a mcg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION XHANCE ® (ex hans) (fluticasone propionate) nasal spray, 93 mcg What is XHANCE? XHANCE is a prescription medicine used to treat: chronic rhinosinusitis with nasal polyps in adults. chronic rhinosinusitis without nasal polyps in adults. It is not known if XHANCE is safe and effective in children.

Do not use XHANCE if you are allergic to fluticasone propionate or any of the ingredients in XHANCE. See the end of this Patient Information leaflet for a complete list of ingredients in XHANCE. Before using XHANCE, tell your healthcare provider about all of your medical conditions, including if you: have or have had nasal sores, nasal surgery, or nasal injury. have eye problems, such as cataracts or glaucoma. have an immune system problem. have any type of viral, bacterial, or fungal infection. are exposed to chickenpox or measles. have weak bones (osteoporosis). have liver problems. are pregnant or plan to become pregnant.

It is not known if XHANCE may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XHANCE passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

XHANCE and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use XHANCE?

Read the Instructions for Use leaflet for information about the right way to use XHANCE. Use XHANCE exactly as your healthcare provider tells you. Do not use XHANCE more often than prescribed.

Ask your healthcare provider if you have any questions. XHANCE is for use in your nose only. Do not spray it in your eyes or mouth.

XHANCE may take several days of regular use for your symptoms to get better. It may take several months for the medicine to have its greatest effect. If your symptoms do not improve or get worse, call your healthcare provider.

You will get the best results if you keep using XHANCE regularly twice each day without missing a dose. Do not stop using XHANCE unless your healthcare provider tells you to do so. If you miss a dose of XHANCE, take it as soon as you remember the same day.

Do not take more than your prescribed dose of XHANCE each day. What are the possible side effects of XHANCE? XHANCE may cause serious side effects, including : Nasal problems .

Symptoms of nasal problems may include: nose bleeds. crusting in the nose. sores (ulcers) in the nose. hole in the cartilage of the nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septum perforation. thrush (candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth. slow wound healing.

You should not use XHANCE until your nose has healed if you have a sore in your nose, have had surgery on your nose, or if your nose has been injured. Eye problems including glaucoma and cataracts . You should have regular eye exams while you use XHANCE.

Call your healthcare provider if you have vision changes while using XHANCE. Serious allergic reactions . Call your healthcare provider or get emergency medical care if you get any of the following signs of a serious allergic reaction: rash hives swelling of your face, mouth, and tongue breathing problems low blood pressure Weakened immune system and increased chance of getting infections (immunosuppression) .

Taking medicines that weaken your immune system makes you more likely to get infections and can make certain infections worse. These infections may include tuberculosis (TB), herpes simplex infections of the eyes (ocular herpes simplex infections), and infections caused b… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use 30 words ▾

INSTRUCTIONS FOR USE – 16 mL and 6.4 mL Information for Use Information for Use Information for Use Information for Use Information for Use Information for Use Information for Use

📄 Recent Major Changes 7 words ▾

Indications and Usage ( 1.2 ) 03/2024

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - Carton Label - Outside - 16 mL NDC 71715-003-31 XHANCE ® (fluticasone propionate) 93 mcg per spray This carton contains: 1 Prefilled XHANCE Unit (each spray contains 93 mcg fluticasone propionate) Shake Before Each Use For Nasal Use Only Rx O NLY 16 mL 120 Metered Sprays NDC 71715-003-31 XHANCE ® (fluticasone propionate) 93 mcg per spray Please read instructions carefully before use. XHANCE includes the Exhalation Delivery System™ (EDS ® ) and fluticasone propionate for nasal use only Store at room temperature (between 15°C and 25°C; 59°F and 77°F) Avoid exposure to extreme heat, cold or light Recommended Dosage: See Prescribing Information Inactive Ingredients: 0.02% w/w benzalkonium chloride, carboxymethylcellulose sodium, dextrose, EDTA, microcrystalline cellulose, polysorbate 80, purified water, sodium hydroxide and hydrochloric acid (to adjust pH) Distributed by: Paratek Pharmaceuticals, Inc., King of Prussia, PA 19406 Made in Portugal XHANCE ® , EDS ® , and Exhalation Delivery System™ are trademarks of Paratek Pharmaceuticals, Inc. and /or its affliated companies.

Patented. See www.XHANCE.com/patents ©2026 Paratek Pharmaceuticals, Inc. All rights reserved.

XHANCE ® (fluticasone propionate) 93 mcg per spray For more information, please visit www.XHANCE.com or call 1-833-678-6673. 16 mL Carton

PRINCIPAL DISPLAY PANEL - Carton Label - Outside - 6.4 mL NDC 71715-003-32 XHANCE ® (fluticasone propionate) 93 mcg per spray This carton contains: 1 Prefilled XHANCE Unit (each spray contains 93 mcg fluticasone propionate) Shake Before Each Use For Nasal Use Only Rx ONLY 6.4mL 28 Metered Sprays NDC 71715-003-32 XHANCE ® (fluticasone propionate) 93 mcg per spray Please read instructions carefully before use. XHANCE includes the Exhalation Delivery System™ (EDS ® ) and fluticasone propionate for nasal use only Store at room temperature (between 15°C and 25°C; 59°F and 77°F) Avoid exposure to extreme heat, cold or light Recommended Dosage: See Prescribing Information Inactive Ingredients: 0.02% w/w benzalkonium chloride, carboxymethylcellulose sodium, dextrose, EDTA, microcrystalline cellulose, polysorbate 80, purified water, sodium hydroxide and hydrochloric acid (to adjust pH) Distributed by: Paratek Pharmaceuticals, Inc., King of Prussia, PA 19406 Made in Portugal XHANCE ® , EDS ® , and Exhalation Delivery System™ are trademarks of Paratek Pharmaceuticals, Inc. and /or its affliated companies.

Patented. See www.XHANCE.com/patents ©2026 Paratek Pharmaceuticals, Inc. All rights reserved.

XHANCE ® (fluticasone propionate) 93 mcg per spray For more information, please visit www.XHANCE.com or call 1-833-678-6673. 6.4 mL Carton

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Xhance — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xhance. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.85M
Claims incl. refills
6.8K
Beneficiaries
4.5K
Spend / beneficiary
$1,311.55
Spend / claim
$858.14
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 XHANCE (this brand).

Top reported reactions

Dyspnoea2,495
Headache2,448
Fatigue2,187
Pain1,900
Nausea1,891
Cough1,824
Asthma1,692

Reporter sex

0 reports

Serious outcomes

Hospitalization7,996
Death1,751
Life-threatening909
Disabling844
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3,664 0
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) — 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) — 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 Paratek Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (71715-0003-32), 1 bottle (71715-0003-33). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Paratek Pharmaceuticals, 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.
← 71715-0002-21 · Paratek 71726-0004-02 · LiquidCapsule →
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.