Rugby mometasone furoate nasal

Product NDC
0536-1381
11-digit product format
005361381
Labeler code
0536
Product ID
0536-1381_83cac9d3-1d41-4dab-895d-5215705746b7
Type
HUMAN OTC DRUG
Nonproprietary name
mometasone furoate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rugby Laboratories
Application
NDA215712
Marketing category
NDA
Marketing start
2023-10-11
Substance
MOMETASONE FUROATE MONOHYDRATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MTW0WEG809MOMETASONE FUROATE MONOHYDRATE141646-00-6MOMETASONE FUROATE MONOHYDRATE
04201GDN4RMOMETASONE FUROATE83919-23-7mometasone furoate

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0536-1381-30005361381301 BOTTLE, SPRAY in 1 CARTON (0536-1381-30) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2023-10-11NoNoHistorical
0536-1381-70005361381701 BOTTLE, SPRAY in 1 CARTON (0536-1381-70) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2023-10-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rugby Laboratories Mometasone Furoate Nasal Spray, 50 mcg Per Spray Drug FactsRugby Laboratories2025-08-06HUMAN OTC DRUG LABEL3