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Active ingredient

Mometasone

54 finished FDA listings contain Mometasone as their only active ingredient; 5 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
MOMETASONE, MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE
Dosage forms
Aerosol, Cream, Implant, Inhalant, Lotion, Ointment, Solution, Spray, Metered
Routes
Intrasinal, Nasal, Respiratory (Inhalation), Topical
Manufacturers / labelers
26
Strengths listed
1 mg/1 · 1 mg/g · 1 mg/ml · 100 ug/1 · 110 ug/1 · 1350 ug/1 · 200 ug/1 · 220 ug/1 · 50 ug/1
Brand names in FDA listings
Allergy, Allergy Nasal, Allergy Relief, Asmanex, Asmanex Hfa, Basic Care Allergy, Childrens Nasonex, Leader Allergy Nasal, Nasonex, Rugby Mometasone Furoate Nasal, Sinuva, Topcare Allergy

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 108118

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 076067PADAGIS US2002-03-1810
ANDA 076481ENCUBE2003-11-141
ANDA 076679SUN PHARMA CANADA2004-12-218
NDA 021067ORGANON LLC2005-03-302
ANDA 077180PADAGIS ISRAEL2005-04-064
ANDA 077447COSETTE PHARMS NC2006-05-223
ANDA 077401COSETTE PHARMS NC2006-06-201
ANDA 076499ENCUBE2007-11-211
ANDA 078541GLENMARK PHARMS2008-05-282
ANDA 090506GLENMARK PHARMS LTD2010-08-091
NDA 205641ORGANON LLC2014-04-253
ANDA 091161APOTEX2016-03-222
NDA 209310INTERSECT ENT INC2017-12-081
ANDA 207899TORRENT2018-07-131
NDA 215712PERRIGO PHARMA INTL2022-03-1712
ANDA 215878AUROBINDO PHARMA2024-03-181
ANDA 217498AUROBINDO PHARMA2024-11-221

Official labeling on DailyMed

Showing the 12 most recent of 49 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.