FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby mometasone furoate nasal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE MONOHYDRATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMTW0WEG809
Rxcui1797865

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1381-30Rugby mometasone furoate nasal120 in 1 BOTTLE, SPRAYSPRAY, METERED1203
0536-1381-30Rugby mometasone furoate nasal1 in 1 CARTONSPRAY, METERED13
0536-1381-70Rugby mometasone furoate nasal1 in 1 CARTONSPRAY, METERED13
0536-1381-70Rugby mometasone furoate nasal60 in 1 BOTTLE, SPRAYSPRAY, METERED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1381-30ML - Milliliter0536-1381c512e58e-5342-44ae-8362-46b9a5f55b7012024-04-05
0536-1381-70ML - Milliliter0536-138158b9c732-e50c-4bf6-9398-3e98a8f9d5cc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1381RUGBY MOMETASONE FUROATE NASAL (MOMETASONE FUROATE) SPRAY, METERED [RUGBY LABORATORIES]2Current NDC, 4 package rows20240906_b4c43535-ad22-44c2-b04f-df4348a6c485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNb4c43535-ad22-44c2-b04f-df4348a6c4853
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDb4c43535-ad22-44c2-b04f-df4348a6c4853
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYb4c43535-ad22-44c2-b04f-df4348a6c4853

Packages#

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