FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
53002-8320
11-digit product format
530028320
Labeler code
53002
Product ID
53002-8320_8c1146e4-4995-42b4-8ac2-eaa177447eac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078541
Marketing category
ANDA
Marketing start
2008-05-28
Marketing end
0000-00-00
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-8320-12025-01-30C16284748780-1f386c649-e09d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE Cream, 0.1% for topical use Initial U.S. Approval: 1987
53002-8320-12023-06-08C16284748780-1f386c649-e09d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE Cream, 0.1% for topical use Initial U.S. Approval: 1987
53002-8320-12023-01-30C16284748780-1f386c649-e09d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE Cream, 0.1% for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8320-1Mometasone Furoate15 g in 1 TUBECREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8320MOMETASONE FUROATE CREAM [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_e9f35bc7-6792-47fd-a706-2b3b19c05686.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSNe9f35bc7-6792-47fd-a706-2b3b19c056863
311753mometasone furoate 1 MG/ML Topical CreamSCDe9f35bc7-6792-47fd-a706-2b3b19c056863
311753mometasone furoate 0.1 % Topical CreamSYe9f35bc7-6792-47fd-a706-2b3b19c056863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8320-15300283200115 g in 1 TUBE (53002-8320-1) 15 g2018-10-010000-00-00NoNoCurrent