FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
45802-119
11-digit product format
458020119
Labeler code
45802
Product ID
45802-119_984a7f85-0039-4199-831a-368d5050a5be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076067
Marketing category
ANDA
Marketing start
2008-07-18
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
45802-119-37Mometasone Furoate1 in 1 CARTONOINTMENT19
45802-119-37Mometasone Furoate15 g in 1 TUBEOINTMENT159
45802-119-42Mometasone Furoate45 g in 1 TUBEOINTMENT459
45802-119-42Mometasone Furoate1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-119-37GM - Gram45802-11964b09fa0-6aaf-45bb-abe2-12ad92766c3e12012-07-24
45802-119-42GM - Gram45802-11990f5b3f7-3b0f-45ef-af8e-fdc361543f0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-119MOMETASONE FUROATE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20240509_d986282f-da3c-43b6-a3f6-40886d4a1915.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN43a91066-1d85-4f67-9856-a11c1bb2b22b104
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD43a91066-1d85-4f67-9856-a11c1bb2b22b104
151029mometasone furoate 0.1 % Topical OintmentSY43a91066-1d85-4f67-9856-a11c1bb2b22b104
151029mometasone furoate 1 MG/GM Topical OintmentSY43a91066-1d85-4f67-9856-a11c1bb2b22b104
151029mometasone furoate 0.1 % Topical OintmentPSNa6055a9c-e19c-48ad-a743-c0a7f7366cdd103
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDa6055a9c-e19c-48ad-a743-c0a7f7366cdd103
151029mometasone furoate 0.1 % Topical OintmentSYa6055a9c-e19c-48ad-a743-c0a7f7366cdd103
151029mometasone furoate 1 MG/GM Topical OintmentSYa6055a9c-e19c-48ad-a743-c0a7f7366cdd103
151029mometasone furoate 0.1 % Topical OintmentPSN45c9512b-9463-4684-bfdb-742644d77cc3102
151029mometasone furoate 0.1 % Topical OintmentPSNc3053a64-9044-496e-9005-12b4440d46e8102
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD45c9512b-9463-4684-bfdb-742644d77cc3102
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDc3053a64-9044-496e-9005-12b4440d46e8102
151029mometasone furoate 0.1 % Topical OintmentSY45c9512b-9463-4684-bfdb-742644d77cc3102
151029mometasone furoate 0.1 % Topical OintmentSYc3053a64-9044-496e-9005-12b4440d46e8102
151029mometasone furoate 1 MG/GM Topical OintmentSYc3053a64-9044-496e-9005-12b4440d46e8102
151029mometasone furoate 1 MG/GM Topical OintmentSY45c9512b-9463-4684-bfdb-742644d77cc3102
151029mometasone furoate 0.1 % Topical OintmentPSN5eda1256-001a-4f40-b3ca-15349d532033101
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD5eda1256-001a-4f40-b3ca-15349d532033101
151029mometasone furoate 0.1 % Topical OintmentSY5eda1256-001a-4f40-b3ca-15349d532033101
151029mometasone furoate 1 MG/GM Topical OintmentSY5eda1256-001a-4f40-b3ca-15349d532033101
151029mometasone furoate 0.1 % Topical OintmentPSN9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.1 % Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 1 MG/GM Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.1 % Topical OintmentPSNd986282f-da3c-43b6-a3f6-40886d4a19159
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDd986282f-da3c-43b6-a3f6-40886d4a19159
151029mometasone furoate 0.1 % Topical OintmentSYd986282f-da3c-43b6-a3f6-40886d4a19159
151029mometasone furoate 1 MG/GM Topical OintmentSYd986282f-da3c-43b6-a3f6-40886d4a19159
151029mometasone furoate 0.1 % Topical OintmentPSNbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 0.1 % Topical OintmentSYbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 1 MG/GM Topical OintmentSYbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 0.1 % Topical OintmentPSNc08fcb0d-7fff-4d90-aeb8-e912b930bf3d1
151029mometasone furoate 0.1 % Topical OintmentPSNf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDc08fcb0d-7fff-4d90-aeb8-e912b930bf3d1
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 0.1 % Topical OintmentSYc08fcb0d-7fff-4d90-aeb8-e912b930bf3d1
151029mometasone furoate 0.1 % Topical OintmentSYf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 1 MG/GM Topical OintmentSYc08fcb0d-7fff-4d90-aeb8-e912b930bf3d1
151029mometasone furoate 1 MG/GM Topical OintmentSYf02dea3f-9e4f-4c5a-bea3-f428afca803b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-119-37458020119371 TUBE in 1 CARTON (45802-119-37) / 15 g in 1 TUBE1 tube2008-07-180000-00-00NoNoCurrent
45802-119-42458020119421 TUBE in 1 CARTON (45802-119-42) / 45 g in 1 TUBE1 tube2008-07-300000-00-00NoNoCurrent