topcare allergy

Product NDC
76162-134
11-digit product format
761620134
Labeler code
76162
Product ID
76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41
Type
HUMAN OTC DRUG
Nonproprietary name
mometasone furoate monohydrate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Topco Associates LLC
Application
NDA215712
Marketing category
NDA
Marketing start
2023-03-28
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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76162-134-02761620134021 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2023-03-28NoNoHistorical
76162-134-11761620134111 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2024-03-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Associates LLC. Allergy Spray Drug FactsTopco Associates LLC2024-08-29HUMAN OTC DRUG LABEL4