FDA.reportPublic FDA data

MOMETASONE FUROATE

Product NDC
60505-0830
11-digit product format
605050830
Labeler code
60505
Product ID
60505-0830_0fea4b16-5a47-9b03-d16f-993b04f2d59e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOMETASONE FUROATE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA091161
Marketing category
ANDA
Marketing start
2016-03-22
Substance
MOMETASONE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8HR4QJ6DW8
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
60505-0830-1MOMETASONE FUROATE1 in 1 CARTONSPRAY, METERED112
60505-0830-1MOMETASONE FUROATE120 in 1 BOTTLE, PUMPSPRAY, METERED12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0830-1GM - Gram60505-08300317e825-953e-4a3e-ada3-1951d3a3180512016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0830MOMETASONE FUROATE SPRAY, METERED [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20250507_48f7ba0d-33e0-163b-2fa0-f85062768fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN48f7ba0d-33e0-163b-2fa0-f85062768fd512
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe30ca373-d9c0-4cad-b5c3-3be9c299dddc12
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD48f7ba0d-33e0-163b-2fa0-f85062768fd512
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe30ca373-d9c0-4cad-b5c3-3be9c299dddc12
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySY48f7ba0d-33e0-163b-2fa0-f85062768fd512
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe30ca373-d9c0-4cad-b5c3-3be9c299dddc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0830-1605050830011 BOTTLE, PUMP in 1 CARTON (60505-0830-1) / 120 SPRAY, METERED in 1 BOTTLE, PUMP2016-03-220000-00-00NoNoCurrent