Prescription medicine
Formoterol and mometasone Brand names: Dulera
Formoterol and mometasone (Dulera) is a prescription medicine with an FDA approval on record since 2010. No generic is listed; pharmacies paid $25.22 per gram (Dulera 100 mcg-5 mcg inhaler) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the formoterol and mometasone FDA label on DailyMed (effective July 10, 2026); the NDA 22518 record on Drugs@FDA; every formoterol and mometasone label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDULERA 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.
Forms and strengths
Aerosol.
On the market
- Earliest approval on file
- June 22, 2010 Dulera, Organon Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $25.22 per gram Dulera 100 mcg-5 mcg inhaler
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 15,502 through July 30, 2026
What is formoterol and mometasone used for?
From the label: indications and usageDULERA 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. ( 1.1 ) Important Limitation of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). […]
Conditions named in the indications of formoterol and mometasone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Corticosteroid and beta2-Adrenergic Agonist.
Source: FDA drug label (Dulera), Organon LLC, effective July 10, 2026 (SPL set 8f399784-f257-4f31-b3dc-368bf2a1864d), via openFDA; the full label on DailyMed
Is there a generic for formoterol and mometasone (Dulera)?
No generic formoterol and mometasone is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for formoterol and mometasone (Dulera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $25.22 per gram (Dulera 100 mcg-5 mcg inhaler), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dulera 100 mcg-5 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dulera 100 mcg-5 mcg inhaler | Brand | $25.22 per gram | n/a | -0.1% |
| Dulera 200 mcg-5 mcg inhaler | Brand | $25.22 per gram | n/a | -0.1% |
| Dulera 50 mcg-5 mcg inhaler | Brand | $25.19 per gram | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the formoterol and mometasone label say about other medicines?
The formoterol and mometasone label names 13 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. |
| Arformoterol | warnings and precautions | Patients using DULERA should not use an additional long-acting beta 2 -agonist (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma. |
| Atazanavir | drug interactions | Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and … |
| Budesonide | warnings and precautions | … propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; and one trial compared budesonide/formoterol to budesonide. |
| Clarithromycin | drug interactions | Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and … |
| Fluticasone | warnings and precautions | Three trials included adult and adolescent patients aged ≥12 years: one trial compared mometasone furoate/formoterol (DULERA) to mometasone furoate [see Clinical Studies (14.1) ]; one trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; … |
| Itraconazole | drug interactions | Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and … |
| Ketoconazole | drug interactions | After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled mometasone furoate increased. |
| Nefazodone | drug interactions | Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and … |
| Nelfinavir | drug interactions | Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and … |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. |
| Salmeterol | warnings and precautions | Serious Asthma-Related Events – Hospitalizations, Intubations, and Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART) ]. |
Source: FDA drug label (Dulera), Organon LLC, effective July 10, 2026 (SPL set 8f399784-f257-4f31-b3dc-368bf2a1864d), via openFDA; the full label on DailyMed
What do FAERS reports show for formoterol and mometasone?
The FDA Adverse Event Reporting System holds 15,502 reports that list formoterol and mometasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 438 are coded as a death and 2,478 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as formoterol and mometasone?
10 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as formoterol and mometasone or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol | Asthma | 33 labelers | $0.0612 per mL 2.5 mg/3 mL solution | Resolved |
| Fluticasone and salmeterol | Asthma | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Budesonide | Asthma | 13 labelers | $0.676 per mL 0.5 mg/2 mL suspension | No current entry |
| Fluticasone | Asthma | 1 labeler | $11.82 per gram 44 mcg inhaler | No current entry |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
| Fluticasone and vilanterol | Asthma | none listed | $3.90 per unit 100-25 | No current entry |
| Fluticasone and umeclidinium and vilanterol | Asthma | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Albuterol and budesonide | Asthma | none listed | $45.03 per gram 90-80 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as formoterol and mometasone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to formoterol and mometasone
- 10 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Formoterol and mometasone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other