FDA.reportPublic FDA data

Mupirocin

Product NDC
53002-9851
11-digit product format
530029851
Labeler code
53002
Product ID
53002-9851_2dc44d72-8b34-4fbd-8aaa-5a21f03e4f77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065170
Marketing category
ANDA
Marketing start
2005-09-23
Marketing end
0000-00-00
Substance
MUPIROCIN
Active strength
20 mg/g
Pharmacologic classes
RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [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
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9851-12025-01-30C16284748780-19d75b9d0-64b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
53002-9851-12023-06-08C16284748780-19d75b9d0-64b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
53002-9851-12023-01-30C16284748780-19d75b9d0-64b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
53002-9851-12020-12-17C16284748780-19d75b9d0-64b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
53002-9851-12020-01-31C16284748780-19d75b9d0-64b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9851-1Mupirocin22 g in 1 TUBEOINTMENT225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9851MUPIROCIN OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_f41c04f9-33fb-47ae-a54d-a4292e559784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 0.02 MG/MG Topical OintmentSCDf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 2 % Topical OintmentSYf41c04f9-33fb-47ae-a54d-a4292e5597845
106346mupirocin 20 MG per GM Topical OintmentSYf41c04f9-33fb-47ae-a54d-a4292e5597845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9851-15300298510122 g in 1 TUBE (53002-9851-1) 22 g2018-10-010000-00-00NoNoCurrent