FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
0713-0635
11-digit product format
007130635
Labeler code
0713
Product ID
0713-0635_0b4770a7-60b1-f27f-e063-6394a90a16a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA077401
Marketing category
ANDA
Marketing start
2014-03-04
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
0713-0635-15Mometasone Furoate1 in 1 CARTONOINTMENT18
0713-0635-15Mometasone Furoate15 g in 1 TUBEOINTMENT158
0713-0635-37Mometasone Furoate1 in 1 CARTONOINTMENT18
0713-0635-37Mometasone Furoate45 g in 1 TUBEOINTMENT458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0635-15GM - Gram0713-0635ab2fa958-2e07-4801-a696-9c34105e440112012-07-24
0713-0635-37GM - Gram0713-063506b77644-d7ac-4eaf-94a2-01b63716412b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
MOMETASONE FUROATEACTIVE MOIETY04201GDN4RMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
Propylene Glycol StearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
White WaxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.]2
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Mometasone FuroateACTIVE MOIETY04201GDN4RMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Mometasone FuroateACTIVE MOIETY04201GDN4RMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Propylene Glycol MonopalmitostearateINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1
White WaxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.]1
White WaxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0635MOMETASONE FUROATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20231130_f5b30e5e-b067-e28c-b7c5-aa58f4c57f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNf5b30e5e-b067-e28c-b7c5-aa58f4c57f098
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDf5b30e5e-b067-e28c-b7c5-aa58f4c57f098
151029mometasone furoate 0.1 % Topical OintmentSYf5b30e5e-b067-e28c-b7c5-aa58f4c57f098
151029mometasone furoate 1 MG/GM Topical OintmentSYf5b30e5e-b067-e28c-b7c5-aa58f4c57f098
151029mometasone furoate 0.1 % Topical OintmentPSN8c0c49c9-aa28-4587-869e-b403681525402
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD8c0c49c9-aa28-4587-869e-b403681525402
151029mometasone furoate 0.1 % Topical OintmentSY8c0c49c9-aa28-4587-869e-b403681525402
151029mometasone furoate 1 MG/GM Topical OintmentSY8c0c49c9-aa28-4587-869e-b403681525402
151029mometasone furoate 0.1 % Topical OintmentPSN79957ee5-5d59-45a9-8ff8-10cc75848d2a1
151029mometasone furoate 0.1 % Topical OintmentPSNdb303d11-eba4-49f7-bf9c-7d944ddb43e71
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD79957ee5-5d59-45a9-8ff8-10cc75848d2a1
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDdb303d11-eba4-49f7-bf9c-7d944ddb43e71
151029mometasone furoate 0.1 % Topical OintmentSY79957ee5-5d59-45a9-8ff8-10cc75848d2a1
151029mometasone furoate 0.1 % Topical OintmentSYdb303d11-eba4-49f7-bf9c-7d944ddb43e71
151029mometasone furoate 1 MG/GM Topical OintmentSY79957ee5-5d59-45a9-8ff8-10cc75848d2a1
151029mometasone furoate 1 MG/GM Topical OintmentSYdb303d11-eba4-49f7-bf9c-7d944ddb43e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0635-15007130635151 TUBE in 1 CARTON (0713-0635-15) / 15 g in 1 TUBE1 tube2014-03-040000-00-00NoNoCurrent
0713-0635-37007130635371 TUBE in 1 CARTON (0713-0635-37) / 45 g in 1 TUBE1 tube2014-03-040000-00-00NoNoCurrent