FDA.reportPublic FDA data

Mupirocin

Product NDC
53002-9850
11-digit product format
530029850
Labeler code
53002
Product ID
53002-9850_85c1dc01-3267-4400-95b6-892cd1ee763c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090480
Marketing category
ANDA
Marketing start
2011-06-08
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
53002-9850-12025-01-30C16284748780-19d75b9d0-c733-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
53002-9850-12023-06-08C16284748780-19d75b9d0-c733-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
53002-9850-12023-01-30C16284748780-19d75b9d0-c733-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
53002-9850-12020-12-17C16284748780-19d75b9d0-c733-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
53002-9850-12020-01-31C16284748780-19d75b9d0-c733-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
53002-9850-1Mupirocin22 g in 1 TUBEOINTMENT225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9850MUPIROCIN OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_e0ea94ea-89d4-4caf-9189-d29fda1c3735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNe0ea94ea-89d4-4caf-9189-d29fda1c37355
106346mupirocin 0.02 MG/MG Topical OintmentSCDe0ea94ea-89d4-4caf-9189-d29fda1c37355
106346mupirocin 2 % Topical OintmentSYe0ea94ea-89d4-4caf-9189-d29fda1c37355
106346mupirocin 20 MG per GM Topical OintmentSYe0ea94ea-89d4-4caf-9189-d29fda1c37355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9850-15300298500122 g in 1 TUBE (53002-9850-1) 22 g2017-10-010000-00-00NoNoCurrent