Quick answers
- What is Mometasone furoate and formoterol fumarate dihydrate used for?
- The FDA-approved label (Dulera, Organon LLC, July 10, 2026) says: “DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. Important Limitation of Use: Not indicated for the relief of acute bronchospasm. 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mometasone furoate and formoterol fumarate dihydrate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mometasone furoate and formoterol fumarate dihydrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mometasone furoate and formoterol fumarate dihydrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mometasone furoate and formoterol fumarate dihydrate?
- 1 company lists prescription products of Mometasone furoate and formoterol fumarate dihydrate in the FDA NDC Directory, including Organon LLC.
What Mometasone furoate and formoterol fumarate dihydrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. Important Limitation of Use: Not indicated for the relief of acute bronchospasm. 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. …
— FDA label: Dulera, Organon LLC, effective July 10, 2026. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Aerosol |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Dulera |
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 |
|---|---|---|
| formoterol fumarate 5 ug · mometasone furoate 100 ug aerosol | Brand: Dulera | $25.18–$25.23 per gram 2 packages, lowest to highest |
| formoterol fumarate 5 ug · mometasone furoate 200 ug aerosol | Brand: Dulera | $25.18–$25.28 per gram 2 packages, lowest to highest |
| formoterol fumarate 5 ug · mometasone furoate 50 ug aerosol | Brand: Dulera | $25.19 per gram |
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.
- Organon LLC3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022518 DULERA | Organon LLC | June 22, 2010 | 24, latest June 5, 2025 2025: Manufacturing (CMC) · 2019: Efficacy · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dulera, Organon LLC, effective July 10, 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 →