FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
50090-2991
11-digit product format
500902991
Labeler code
50090
Product ID
50090-2991_273d889a-9b9f-463d-8f73-9d2152a57e92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA077447
Marketing category
ANDA
Marketing start
2006-08-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mometasone Furoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui311753

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
50090-2991-02023-03-20C16284748780-19d75b9d0-516d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOMETASONE FUROATE CREAM, USP safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM, USP. MOMETASONE FUROATE cream, USP for topical use Initial U.S. Approval: 1987
50090-2991-02020-01-31C16284748780-19d75b9d0-516d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOMETASONE FUROATE CREAM, USP safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM, USP. MOMETASONE FUROATE cream, USP for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2991-0Mometasone Furoate45 g in 1 TUBECREAM4512
50090-2991-0Mometasone Furoate1 in 1 CARTONCREAM112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2991-0GM - Gram50090-2991b01fa77c-edfd-4025-96e8-d4bcd831edd912021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2991MOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20230317_16e134c7-39fb-4d16-9c24-a6df438967bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSN16e134c7-39fb-4d16-9c24-a6df438967bf12
311753mometasone furoate 1 MG/ML Topical CreamSCD16e134c7-39fb-4d16-9c24-a6df438967bf12
311753mometasone furoate 0.1 % Topical CreamSY16e134c7-39fb-4d16-9c24-a6df438967bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-2991-0500902991001 TUBE in 1 CARTON (50090-2991-0) / 45 g in 1 TUBE1 tube2017-04-28NoNoHistorical