Home RxNorm 1660934 60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1660934
RxNorm name 60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]
Display name DULERA (Inhalant)
Full name 60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]
Term type SBD
Status Active
Strength 5-100 mcg/puff
Dose form MDI 60 puff
Route Inhalant
Updated 2026-10-20 20:49:41 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 092015
Active start 092015
Multiple ingredient YES
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength mometasone furoate 100 MCG / 1 ACTUAT mometasone mometasone furoate formoterol fumarate 5 MCG / 1 ACTUAT formoterol formoterol fumarate
Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 78206-127-02 78206-127 Dulera mometasone furoate and formoterol fumarate dihydrate Organon LLC NDA022518
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA022518 78206-127 Dulera mometasone furoate and formoterol fumarate dihydrate NDA Organon LLC
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.
NDC11, Source, Active table NDC11 Source Active 78206012702 rxnav_ndcs yes 78206012759 rxnav_ndcs yes 00085720607 rxnav_historical 00085720608 rxnav_historical
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Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective 8f399784-f257-4f31-b3dc-368bf2a1864d Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations [PSN] · 60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera] [SBD] · Dulera (mometasone furoate 100 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 60 ACTUAT [SY] · Dulera 100 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY] · Dulera 100/5 Metered Dose Inhaler, 60 ACTUAT [SY] 5 7 These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010 20260130
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective 8f399784-f257-4f31-b3dc-368bf2a1864d These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010 Organon LLC 20260710 8f399784-f257-4f31-b3dc-368bf2a1864d These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010 Organon LLC 20260130 116464ce-cfd8-4b9f-8b5a-3a114b6ff2b1 These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010 Merck Sharp & Dohme Corp. 20201204 7bf9eccc-ee3a-402d-a16c-b5724bf76aee National Council for Prescription Drug Programs 20120724
Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics ATC1-4 formoterol / mometasone ATC R01AD Corticosteroids ATC1-4 mometasone ATC D07AC Corticosteroids, potent (group III) ATC1-4 mometasone ATC D07XC Corticosteroids, potent, other combinations ATC1-4 mometasone ATC R03BA Glucocorticoids ATC1-4 mometasone ATC R03CC Selective beta-2-adrenoreceptor agonists ATC1-4 formoterol ATC R03AC Selective beta-2-adrenoreceptor agonists ATC1-4 formoterol FDASPL N0000175779 beta2-Adrenergic Agonist EPC has_epc formoterol FDASPL N0000175576 Corticosteroid EPC has_epc mometasone FDASPL N0000009922 Adrenergic beta2-Agonists MOA has_moa formoterol FDASPL N0000175450 Corticosteroid Hormone Receptor Agonists MOA has_moa mometasone MEDRT D000068759 Formoterol Fumarate CHEM has_ingredient formoterol MEDRT D000068759 Formoterol Fumarate CHEM has_ingredient formoterol fumarate MEDRT D000068656 Mometasone Furoate CHEM has_ingredient mometasone MEDRT D000068656 Mometasone Furoate CHEM has_ingredient mometasone furoate MEDRT D000208 Acute Disease DISEASE ci_with formoterol MEDRT D000208 Acute Disease DISEASE ci_with formoterol fumarate MEDRT D001249 Asthma DISEASE ci_with formoterol MEDRT D001249 Asthma DISEASE may_treat formoterol MEDRT D001249 Asthma DISEASE may_treat formoterol fumarate MEDRT D001249 Asthma DISEASE ci_with formoterol fumarate MEDRT D001250 Asthma, Exercise-Induced DISEASE may_prevent formoterol MEDRT D001250 Asthma, Exercise-Induced DISEASE may_prevent formoterol fumarate MEDRT D001986 Bronchial Spasm DISEASE may_treat formoterol MEDRT D001986 Bronchial Spasm DISEASE may_prevent formoterol MEDRT D001986 Bronchial Spasm DISEASE may_treat formoterol fumarate MEDRT D001986 Bronchial Spasm DISEASE may_prevent formoterol fumarate MEDRT D003881 Dermatomycoses DISEASE ci_with mometasone furoate MEDRT D003881 Dermatomycoses DISEASE ci_with mometasone MEDRT D004342 Drug Hypersensitivity DISEASE ci_with mometasone MEDRT D004342 Drug Hypersensitivity DISEASE ci_with mometasone furoate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with formoterol fumarate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with formoterol MEDRT D005148 Facial Dermatoses DISEASE may_treat mometasone MEDRT D005148 Facial Dermatoses DISEASE may_treat mometasone furoate MEDRT D005533 Foot Dermatoses DISEASE may_treat mometasone furoate MEDRT D005533 Foot Dermatoses DISEASE may_treat mometasone MEDRT D006229 Hand Dermatoses DISEASE may_treat mometasone MEDRT D006229 Hand Dermatoses DISEASE may_treat mometasone furoate MEDRT D006561 Herpes Simplex DISEASE ci_with mometasone furoate MEDRT D006561 Herpes Simplex DISEASE ci_with mometasone MEDRT D006562 Herpes Zoster DISEASE ci_with mometasone furoate MEDRT D006562 Herpes Zoster DISEASE ci_with mometasone MEDRT D006967 Hypersensitivity DISEASE ci_with mometasone furoate MEDRT D007249 Inflammation DISEASE may_treat mometasone MEDRT D007249 Inflammation DISEASE may_treat mometasone furoate MEDRT D007868 Leg Dermatoses DISEASE may_treat mometasone MEDRT D007868 Leg Dermatoses DISEASE may_treat mometasone furoate MEDRT D011537 Pruritus DISEASE may_treat mometasone MEDRT D011537 Pruritus DISEASE may_treat mometasone furoate MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat mometasone MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat mometasone furoate MEDRT D012536 Scalp Dermatoses DISEASE may_treat mometasone furoate MEDRT D012536 Scalp Dermatoses DISEASE may_treat mometasone MEDRT D014382 Tuberculosis, Cutaneous DISEASE ci_with mometasone MEDRT D014382 Tuberculosis, Cutaneous DISEASE ci_with mometasone furoate MEDRT N0000009922 Adrenergic beta2-Agonists MOA has_moa formoterol fumarate MEDRT N0000009922 Adrenergic beta2-Agonists MOA has_moa formoterol MEDRT N0000000159 Glucocorticoid Receptor Agonists MOA has_moa mometasone furoate MEDRT N0000000159 Glucocorticoid Receptor Agonists MOA has_moa mometasone MEDRT N0000000134 Lipoxygenase Inhibitors MOA has_moa mometasone furoate MEDRT N0000000134 Lipoxygenase Inhibitors MOA has_moa mometasone MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa formoterol MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa formoterol fumarate MEDRT N0000008322 Bronchodilation PE has_pe formoterol MEDRT N0000008322 Bronchodilation PE has_pe formoterol fumarate MEDRT N0000008681 Decreased Leukotriene Activity PE has_pe mometasone MEDRT N0000008681 Decreased Leukotriene Activity PE has_pe mometasone furoate MEDRT N0000008834 Decreased Prostaglandin Activity PE has_pe mometasone MEDRT N0000008834 Decreased Prostaglandin Activity PE has_pe mometasone furoate MEDRT N0000008841 Decreased Protein Synthesis PE has_pe mometasone MEDRT N0000008841 Decreased Protein Synthesis PE has_pe mometasone furoate MEDRT N0000009004 Decreased Thromboxane Activity PE has_pe mometasone MEDRT N0000009004 Decreased Thromboxane Activity PE has_pe mometasone furoate MEDRT N0000009908 Vasoconstriction PE has_pe mometasone MEDRT N0000009908 Vasoconstriction PE has_pe mometasone furoate
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 0.005 MG/ACTUAT (expressed as formoterol fumarate) / 0.1 MG/ACTUAT (expressed as mometasone furoate) ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES QUANTITY 60 ACTUAT ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA022518 NAMES Prescribable Synonym Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon