FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
0713-0634
11-digit product format
007130634
Labeler code
0713
Product ID
0713-0634_0b473eaf-fbda-c8ed-e063-6394a90ab80a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
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
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
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
0713-0634-15Mometasone Furoate1 in 1 CARTONCREAM19
0713-0634-15Mometasone Furoate15 g in 1 TUBECREAM159
0713-0634-37Mometasone Furoate45 g in 1 TUBECREAM459
0713-0634-37Mometasone Furoate1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0634-15GM - Gram0713-0634333c4561-d29c-4ceb-b7a4-b21cee38c20112012-07-24
0713-0634-37GM - Gram0713-0634b568c7e9-0587-45d5-be2b-9cffe20f2b8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Aluminum Starch OctenylsuccinateINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Propylene Glycol StearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
White WaxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE (MOMETASONE FUROATE) CREAM [G&W LABORATORIES, INC.]2
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
Mometasone FuroateACTIVE MOIETY04201GDN4RMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1
White WaxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0634MOMETASONE FUROATE CREAM [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20231130_f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92.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
311753mometasone furoate 0.1 % Topical CreamPSNf69603aa-a5a6-b8f3-c9ed-2d0abc9f4d929
311753mometasone furoate 1 MG/ML Topical CreamSCDf69603aa-a5a6-b8f3-c9ed-2d0abc9f4d929
311753mometasone furoate 0.1 % Topical CreamSYf69603aa-a5a6-b8f3-c9ed-2d0abc9f4d929
311753mometasone furoate 0.1 % Topical CreamPSN09182072-d05e-4cd4-93c0-d1c0abd6069d1
311753mometasone furoate 0.1 % Topical CreamPSNad47cceb-e471-48d6-85d6-e4a3f10e2ac61
311753mometasone furoate 1 MG/ML Topical CreamSCD09182072-d05e-4cd4-93c0-d1c0abd6069d1
311753mometasone furoate 1 MG/ML Topical CreamSCDad47cceb-e471-48d6-85d6-e4a3f10e2ac61
311753mometasone furoate 0.1 % Topical CreamSY09182072-d05e-4cd4-93c0-d1c0abd6069d1
311753mometasone furoate 0.1 % Topical CreamSYad47cceb-e471-48d6-85d6-e4a3f10e2ac61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0634-15007130634151 TUBE in 1 CARTON (0713-0634-15) / 15 g in 1 TUBE1 tube2006-08-230000-00-00NoNoCurrent
0713-0634-37007130634371 TUBE in 1 CARTON (0713-0634-37) / 45 g in 1 TUBE1 tube2006-08-230000-00-00NoNoCurrent