FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
53002-8321
11-digit product format
530028321
Labeler code
53002
Product ID
53002-8321_7d85b2c7-3d5c-4a0d-b7fb-cb26559040da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076679
Marketing category
ANDA
Marketing start
2004-12-21
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-8321-12025-01-30C16284748780-1f386c649-9bb5-0266-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, for topical use Initial U.S. Approval: 1987
53002-8321-12023-06-08C16284748780-1f386c649-9bb5-0266-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, for topical use Initial U.S. Approval: 1987
53002-8321-12023-01-30C16284748780-1f386c649-9bb5-0266-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, for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8321-1Mometasone Furoate15 g in 1 TUBECREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8321MOMETASONE FUROATE CREAM [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_015a259c-a0cb-4440-b8f2-0a31aa76fb88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8321-15300283210115 g in 1 TUBE (53002-8321-1) 15 g2018-10-010000-00-00NoNoCurrent