FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
50090-1633
11-digit product format
500901633
Labeler code
50090
Product ID
50090-1633_80dfa306-3c97-40f6-9d33-fc1a0171867d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076067
Marketing category
ANDA
Marketing start
2008-07-18
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
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
MOMETASONE FUROATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui151029

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1633-02023-02-17C16284748780-19d75b9d0-9bc5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOMETASONE FUROATE OINTMENT safely and effectively. See full prescribing information for MOMETASONE FUROATE OINTMENT . MOMETASONE FUROATE ointment, for topical use Initial U.S. Approval: 1987
50090-1633-02020-01-31C16284748780-19d75b9d0-9bc5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOMETASONE FUROATE OINTMENT safely and effectively. See full prescribing information for MOMETASONE FUROATE OINTMENT . MOMETASONE FUROATE ointment, for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1633-0Mometasone Furoate15 g in 1 TUBEOINTMENT1510
50090-1633-0Mometasone Furoate1 in 1 CARTONOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1633-0GM - Gram50090-163322f956b9-b00c-435f-ba01-f95ca8ad89d912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1633MOMETASONE FUROATE OINTMENT [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20230219_9fe65193-b4d8-480b-89b3-178cd1b20713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.1 % Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 1 MG/GM Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1633-0500901633001 TUBE in 1 CARTON (50090-1633-0) / 15 g in 1 TUBE1 tube2015-01-15NoNoHistorical