FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
68462-192
11-digit product format
684620192
Labeler code
68462
Product ID
68462-192_42b90831-6019-4d81-aa0d-6fb75c4d51a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078541
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
Rxcui311753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
68462-192-17Mometasone Furoate15 g in 1 TUBECREAM1510
68462-192-55Mometasone Furoate45 g in 1 TUBECREAM4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-192-17GM - Gram68462-19259801fb5-2ab2-4520-a23b-53510bfe9b3112012-07-24
68462-192-55GM - Gram68462-192faa8241b-e8ab-430c-b8b2-fd02d340cae912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-192MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 2 package rows20240104_031283ed-988b-4698-8a2e-00f3d41c0f71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSN031283ed-988b-4698-8a2e-00f3d41c0f7110
311753mometasone furoate 1 MG/ML Topical CreamSCD031283ed-988b-4698-8a2e-00f3d41c0f7110
311753mometasone furoate 0.1 % Topical CreamSY031283ed-988b-4698-8a2e-00f3d41c0f7110
311753mometasone furoate 0.1 % Topical CreamPSN47a60763-671e-413b-b962-f7f11ba2f4d73
311753mometasone furoate 0.1 % Topical CreamPSNc9d7c8b2-de3c-44b1-b22d-1b0c10c46fe93
311753mometasone furoate 0.1 % Topical CreamPSNe9f35bc7-6792-47fd-a706-2b3b19c056863
311753mometasone furoate 1 MG/ML Topical CreamSCD47a60763-671e-413b-b962-f7f11ba2f4d73
311753mometasone furoate 1 MG/ML Topical CreamSCDc9d7c8b2-de3c-44b1-b22d-1b0c10c46fe93
311753mometasone furoate 1 MG/ML Topical CreamSCDe9f35bc7-6792-47fd-a706-2b3b19c056863
311753mometasone furoate 0.1 % Topical CreamSY47a60763-671e-413b-b962-f7f11ba2f4d73
311753mometasone furoate 0.1 % Topical CreamSYc9d7c8b2-de3c-44b1-b22d-1b0c10c46fe93
311753mometasone furoate 0.1 % Topical CreamSYe9f35bc7-6792-47fd-a706-2b3b19c056863
311753mometasone furoate 0.1 % Topical CreamPSN1d856c43-cf09-4746-99b5-af75fba6d2291
311753mometasone furoate 1 MG/ML Topical CreamSCD1d856c43-cf09-4746-99b5-af75fba6d2291
311753mometasone furoate 0.1 % Topical CreamSY1d856c43-cf09-4746-99b5-af75fba6d2291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-192-176846201921715 g in 1 TUBE (68462-192-17) 15 g2008-05-280000-00-00NoNoCurrent
68462-192-556846201925545 g in 1 TUBE (68462-192-55) 45 g2008-05-280000-00-00NoNoCurrent