FDA.reportPublic FDA data

mupirocin

Product NDC
50090-4397
11-digit product format
500904397
Labeler code
50090
Product ID
50090-4397_036900f5-7ccd-4d8b-a50a-6cc652fb3d47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA065123
Marketing category
ANDA
Marketing start
2009-10-30
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
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4397-02023-01-30C16284748780-1f386c649-add2-0266-e053-dadaa90a7c1aThese 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
50090-4397-12023-01-30C16284748780-1f386c649-add2-0266-e053-dadaa90a7c1aThese 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
50090-4397-0mupirocin1 in 1 CARTONOINTMENT11
50090-4397-0mupirocin22 g in 1 TUBEOINTMENT221
50090-4397-1mupirocin1 in 1 CARTONOINTMENT11
50090-4397-1mupirocin22 g in 1 TUBEOINTMENT221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4397MUPIROCIN OINTMENT [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20200825_99eb0412-1d5c-437f-902b-1bc195ae1efa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 0.02 MG/MG Topical OintmentSCD99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 2 % Topical OintmentSY99eb0412-1d5c-437f-902b-1bc195ae1efa1
106346mupirocin 20 MG per GM Topical OintmentSY99eb0412-1d5c-437f-902b-1bc195ae1efa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4397-0500904397001 TUBE in 1 CARTON (50090-4397-0) > 22 g in 1 TUBE1 tube2019-06-280000-00-00NoNoCurrent
50090-4397-1500904397011 TUBE in 1 CARTON (50090-4397-1) > 22 g in 1 TUBE1 tube2019-06-280000-00-00NoNoCurrent