FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
50090-1026
11-digit product format
500901026
Labeler code
50090
Product ID
50090-1026_4db0520f-79e2-42ef-a80e-d95f727ee4d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA078571
Marketing category
ANDA
Marketing start
2008-05-28
Marketing end
0000-00-00
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-1026-02023-01-30C16284748780-19d75b9d0-7e9d-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, 0.1% for topical use Initial U.S. Approval: 1987
50090-1026-02021-09-15C16284748780-19d75b9d0-7e9d-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, 0.1% for topical use Initial U.S. Approval: 1987
50090-1026-02020-01-31C16284748780-19d75b9d0-7e9d-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, 0.1% for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1026-0Mometasone Furoate15 g in 1 TUBEOINTMENT157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1026-0GM - Gram50090-1026d57a2d53-788b-4276-ba71-9ecde2cb580f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1026MOMETASONE FUROATE OINTMENT [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210916_6e1d81d2-9e07-40d4-8f52-859f26c3776b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 0.1 % Topical OintmentSY6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 1 MG/GM Topical OintmentSY6e1d81d2-9e07-40d4-8f52-859f26c3776b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1026-05009010260015 g in 1 TUBE (50090-1026-0) 15 g2014-11-280000-00-00NoNoCurrent