FDA.reportPublic FDA data

MOMETASONE FUROATE MONOHYDRATE

Product NDC
59651-402
11-digit product format
596510402
Labeler code
59651
Product ID
59651-402_b24f80c5-afe2-4821-9185-2dad3cfe277a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOMETASONE FUROATE MONOHYDRATE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurobindo Pharma Limited
Application
ANDA215878
Marketing category
ANDA
Marketing start
2024-03-18
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
MOMETASONE FUROATE MONOHYDRATE
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
59651-402-17MOMETASONE FUROATE MONOHYDRATE1 in 1 CARTONSPRAY, METERED11
59651-402-17MOMETASONE FUROATE MONOHYDRATE120 in 1 BOTTLE, SPRAYSPRAY, METERED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-402-17GM - Gram59651-4029fb68cc5-5d61-4c2f-af2f-c379651b8d2812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-402MOMETASONE FUROATE MONOHYDRATE SPRAY, METERED [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240326_b24f80c5-afe2-4821-9185-2dad3cfe277a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNb24f80c5-afe2-4821-9185-2dad3cfe277a1
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDb24f80c5-afe2-4821-9185-2dad3cfe277a1
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYb24f80c5-afe2-4821-9185-2dad3cfe277a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-402-17596510402171 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2024-03-18NoNoCurrent