Quick answers
- What is Fluticasone propionate used for?
- The FDA-approved label (Fluticasone Propionate Diskus, Sportpharm LLC, July 28, 2026) says: “Fluticasone Propionate DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use Fluticasone Propionate DISKUS is NOT indicated for the relief of acute bronchospasm. Fluticasone Propionate DISKUS is an inhaled corticosteroid (ICS) indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluticasone propionate have a boxed warning?
- No. None of the 49 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluticasone propionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluticasone propionate been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started February 14, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluticasone propionate?
- 23 companies list prescription products of Fluticasone propionate in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Prasco Laboratories.
What Fluticasone propionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fluticasone Propionate DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use Fluticasone Propionate DISKUS is NOT indicated for the relief of acute bronchospasm. Fluticasone Propionate DISKUS is an inhaled corticosteroid (ICS) indicated for …
— FDA label: Fluticasone Propionate Diskus, Sportpharm LLC, effective July 28, 2026. Read the full label on DailyMed →
The FDA has 49 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 49 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Spray, metered · Powder, metered · Cream · Aerosol, metered · Ointment · Spray · Lotion |
|---|---|
| Route | Nasal · Respiratory (inhalation) · Topical |
| Prescription products | 62 in the FDA NDC Directory |
| Brand names | Fluticasone Propionate Diskus, Xhance, Flovent Diskus, Flovent HFA |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fluticasone propionate 0.005% ointment | Generic | $0.3707–$0.5136 per gram 6 packages, lowest to highest |
| fluticasone propionate 0.05% cream | Generic | $0.2312–$0.3538 per gram 9 packages, lowest to highest |
| fluticasone propionate 0.5 mg/mL lotion | Generic | $2.75 per mL |
| fluticasone propionate 100 ug powder, metered | Generic | $2.06 per unit |
| fluticasone propionate 110 ug aerosol, metered | Generic | $13.56 per gram |
| fluticasone propionate 220 ug aerosol, metered | Generic | $21.78 per gram |
| fluticasone propionate 250 ug powder, metered | Generic | $2.67 per unit |
| fluticasone propionate 44 ug aerosol, metered | Generic | $11.64 per gram |
| fluticasone propionate 50 ug powder, metered | Generic | $1.92 per unit |
| fluticasone propionate 50 ug spray | Generic | $0.4434 per gram |
| fluticasone propionate 50 ug spray, metered | Generic | $0.4434 per gram |
| fluticasone propionate 93 ug spray, metered | Brand: Xhance | $40.84 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions10 products
- Bryant Ranch Prepack8 products
- Prasco Laboratories6 products
- Proficient Rx LP4 products
- Preferred Pharmaceuticals Inc.4 products
- Padagis Israel Pharmaceuticals Ltd3 products
- Asclemed USA, Inc.3 products
- NuCare Pharmaceuticals, Inc.3 products
- Sportpharm LLC3 products
- Remedyrepack Inc.2 products
- Cosette Pharmaceuticals, Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Quality Care Products, LLC1 product
- OptiNose US, Inc.1 product
- Chartwell RX, LLC1 product
- Advagen Pharma Ltd1 product
- Apotex Corp.1 product
- Direct_Rx1 product
- Hikma Pharmaceuticals USA Inc.1 product
- IPG Pharmaceuticals, Inc.1 product
- Paratek Pharmaceuticals, Inc.1 product
- Encube Ethicals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020833 FLOVENT DISKUS 100, FLOVENT DISKUS 250, FLOVENT DISKUS 50 | Glaxo Grp Ltd | September 29, 2000 | 17, latest January 7, 2019 2019: Labeling · 2017: Labeling · 2016: Labeling |
| NDA021433 FLOVENT HFA | Glaxo Grp Ltd | May 14, 2004 | 19, latest August 18, 2021 2021: Labeling · 2019: Labeling · 2017: Labeling |
| NDA209022 XHANCE | Paratek Pharms | September 18, 2017 | 8, latest March 15, 2024 2024: Efficacy · 2023: Labeling · 2023: Labeling |
Generic approvals (14)
- ANDA076451Fougera Pharms · May 14, 2004
- ANDA076633Encube · May 14, 2004
- ANDA076668Padagis Israel · May 14, 2004
- ANDA076793Padagis Israel · May 14, 2004
- ANDA076504Hikma · February 22, 2006
- ANDA077168Cosette Pharms Nc · March 3, 2006
- ANDA077055Cosette Pharms Nc · June 30, 2006
- ANDA077538Apotex · September 12, 2007
- ANDA077570Hikma · January 16, 2008
- ANDA078492Chartwell Rx · January 9, 2012
- ANDA091553Padagis Israel · July 30, 2013
- ANDA218321Rubicon Research · June 5, 2025
- ANDA219602Glenmark Speclt · March 3, 2026
- ANDA219232Glenmark Speclt · August 18, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 14, 2024 · Class II · Ongoing · D-0349-2024
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195- — Golden State Medical Supply Inc.
-
February 9, 2024 · Class II · Ongoing · D-0326-2024
CGMP Deviations: potential presence of Burkholderia cepacia complex
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1 — Apotex Corp.
-
January 26, 2022 · Class II · Terminated · D-0182-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1 — CARDINAL HEALTHCARE
-
May 31, 2018 · Class II · Terminated · D-0841-2018
Presence of foreign substance: glass particles
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apot — Apotex Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fluticasone Propionate Diskus, Sportpharm LLC, effective July 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →