FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
68462-225
11-digit product format
684620225
Labeler code
68462
Product ID
68462-225_68dd082e-2bd7-43d5-9dd2-948bd2cd4637
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078571
Marketing category
ANDA
Marketing start
2008-05-28
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-225-17Mometasone Furoate15 g in 1 TUBEOINTMENT157
68462-225-55Mometasone Furoate45 g in 1 TUBEOINTMENT457

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-225-17GM - Gram68462-2256534eaac-fd1e-4b6f-87c3-eac16f38225c12012-07-24
68462-225-55GM - Gram68462-225cd05156a-4080-434e-9fb1-ea73ca6fba0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-225MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 2 package rows20240104_209c15dd-72b2-4f00-a2f0-011219f7eaea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN209c15dd-72b2-4f00-a2f0-011219f7eaea7
151029mometasone furoate 0.1 % Topical OintmentPSN6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD209c15dd-72b2-4f00-a2f0-011219f7eaea7
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 0.1 % Topical OintmentSY209c15dd-72b2-4f00-a2f0-011219f7eaea7
151029mometasone furoate 0.1 % Topical OintmentSY6e1d81d2-9e07-40d4-8f52-859f26c3776b7
151029mometasone furoate 1 MG/GM Topical OintmentSY209c15dd-72b2-4f00-a2f0-011219f7eaea7
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
68462-225-176846202251715 g in 1 TUBE (68462-225-17) 15 g2008-05-280000-00-00NoNoCurrent
68462-225-556846202255545 g in 1 TUBE (68462-225-55) 45 g2008-05-280000-00-00NoNoCurrent