FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
45802-118
11-digit product format
458020118
Labeler code
45802
Product ID
45802-118_fe1488ac-a59e-4396-846f-d97b41ae7924
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077180
Marketing category
ANDA
Marketing start
2008-12-11
Substance
MOMETASONE FUROATE
Active strength
1 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui151030

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
45802-118-46Mometasone Furoate1 in 1 CARTONSOLUTION17
45802-118-46Mometasone Furoate60 mL in 1 BOTTLESOLUTION607
45802-118-59Mometasone Furoate30 mL in 1 BOTTLESOLUTION307
45802-118-59Mometasone Furoate1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-118-46ML - Milliliter45802-1184062b503-6b12-493e-bede-6311f1bcdb7612012-07-24
45802-118-59ML - Milliliter45802-118565eb877-7120-459e-a56b-ef4f2949b56112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE SOLUTION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-118MOMETASONE FUROATE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 4 package rows20230425_7296b4a2-f180-4887-a8e0-029f81aec566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSN6c7d8133-b71e-4290-bec1-53ff0232998a108
151030mometasone furoate 1 MG/ML Topical LotionSCD6c7d8133-b71e-4290-bec1-53ff0232998a108
151030mometasone furoate 0.1 % Topical LotionSY6c7d8133-b71e-4290-bec1-53ff0232998a108
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSN5f1f2136-9e10-4d43-bb35-ed285c744fe4105
151030mometasone furoate 1 MG/ML Topical LotionSCD5f1f2136-9e10-4d43-bb35-ed285c744fe4105
151030mometasone furoate 0.1 % Topical LotionSY5f1f2136-9e10-4d43-bb35-ed285c744fe4105
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSNd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 1 MG/ML Topical LotionSCDd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 0.1 % Topical LotionSYd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSN7296b4a2-f180-4887-a8e0-029f81aec5667
151030mometasone furoate 1 MG/ML Topical LotionSCD7296b4a2-f180-4887-a8e0-029f81aec5667
151030mometasone furoate 0.1 % Topical LotionSY7296b4a2-f180-4887-a8e0-029f81aec5667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-118-46458020118461 BOTTLE in 1 CARTON (45802-118-46) / 60 mL in 1 BOTTLE1 bottle2008-12-110000-00-00NoNoCurrent
45802-118-59458020118591 BOTTLE in 1 CARTON (45802-118-59) / 30 mL in 1 BOTTLE1 bottle2009-02-020000-00-00NoNoCurrent