FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
45802-257
11-digit product format
458020257
Labeler code
45802
Product ID
45802-257_395c6e1e-e5c9-f36a-e063-6294a90a48d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076679
Marketing category
ANDA
Marketing start
2004-12-21
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
45802-257-35Mometasone Furoate1 in 1 CARTONCREAM111
45802-257-35Mometasone Furoate15 g in 1 TUBECREAM1511
45802-257-42Mometasone Furoate45 g in 1 TUBECREAM4511
45802-257-42Mometasone Furoate1 in 1 CARTONCREAM111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-257-35GM - Gram45802-2574b99deb9-7353-4229-8f26-996da9eafeae12013-02-13
45802-257-42GM - Gram45802-2576dcfa575-b156-4ddf-ac17-c3cd10f6b39e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
aluminum starch octenylsuccinateINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
phosphoric acidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
propylene glycol stearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
waterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [PERRIGO NEW YORK INC.]2
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
aluminum starch octenylsuccinateINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
propylene glycol stearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
white waxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-257MOMETASONE FUROATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 4 package rows20240407_a12fef6b-681e-4f80-8bcd-3f01733f1a67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSN2f79063c-f7da-4e71-b054-d24b86dd386a106
311753mometasone furoate 1 MG/ML Topical CreamSCD2f79063c-f7da-4e71-b054-d24b86dd386a106
311753mometasone furoate 0.1 % Topical CreamSY2f79063c-f7da-4e71-b054-d24b86dd386a106
311753mometasone furoate 0.1 % Topical CreamPSN79e13e15-5bd3-48b1-877a-1cd92abbc7c5105
311753mometasone furoate 1 MG/ML Topical CreamSCD79e13e15-5bd3-48b1-877a-1cd92abbc7c5105
311753mometasone furoate 0.1 % Topical CreamSY79e13e15-5bd3-48b1-877a-1cd92abbc7c5105
311753mometasone furoate 0.1 % Topical CreamPSNc953bd40-8a52-4812-837a-baaf1b17b3aa103
311753mometasone furoate 1 MG/ML Topical CreamSCDc953bd40-8a52-4812-837a-baaf1b17b3aa103
311753mometasone furoate 0.1 % Topical CreamSYc953bd40-8a52-4812-837a-baaf1b17b3aa103
311753mometasone furoate 0.1 % Topical CreamPSN88f5622d-64da-42b7-8aa9-62a5da5ebfbb100
311753mometasone furoate 1 MG/ML Topical CreamSCD88f5622d-64da-42b7-8aa9-62a5da5ebfbb100
311753mometasone furoate 0.1 % Topical CreamSY88f5622d-64da-42b7-8aa9-62a5da5ebfbb100
311753mometasone furoate 0.1 % Topical CreamPSNa12fef6b-681e-4f80-8bcd-3f01733f1a6711
311753mometasone furoate 1 MG/ML Topical CreamSCDa12fef6b-681e-4f80-8bcd-3f01733f1a6711
311753mometasone furoate 0.1 % Topical CreamSYa12fef6b-681e-4f80-8bcd-3f01733f1a6711
311753mometasone furoate 0.1 % Topical CreamPSN2bf06b19-4ed7-41a3-b6fc-29713c41965c4
311753mometasone furoate 1 MG/ML Topical CreamSCD2bf06b19-4ed7-41a3-b6fc-29713c41965c4
311753mometasone furoate 0.1 % Topical CreamSY2bf06b19-4ed7-41a3-b6fc-29713c41965c4
311753mometasone furoate 0.1 % Topical CreamPSN015a259c-a0cb-4440-b8f2-0a31aa76fb883
311753mometasone furoate 1 MG/ML Topical CreamSCD015a259c-a0cb-4440-b8f2-0a31aa76fb883
311753mometasone furoate 0.1 % Topical CreamSY015a259c-a0cb-4440-b8f2-0a31aa76fb883
311753mometasone furoate 0.1 % Topical CreamPSN831f7694-8153-4a79-a453-48020b26f0352
311753mometasone furoate 1 MG/ML Topical CreamSCD831f7694-8153-4a79-a453-48020b26f0352
311753mometasone furoate 0.1 % Topical CreamSY831f7694-8153-4a79-a453-48020b26f0352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-257-35458020257351 TUBE in 1 CARTON (45802-257-35) / 15 g in 1 TUBE1 tube2024-04-050000-00-00NoNoCurrent
45802-257-42458020257421 TUBE in 1 CARTON (45802-257-42) / 45 g in 1 TUBE1 tube2024-04-050000-00-00NoNoCurrent