FDA.reportPublic FDA data

mupirocin

Product NDC
50090-1587
11-digit product format
500901587
Labeler code
50090
Product ID
50090-1587_84a2980e-170d-4cf5-86bf-8a727921d142
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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
mupirocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD0GX863OA5
Rxcui106346

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
50090-1587-02023-02-06C16284748780-1f386c649-aee5-0266-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
50090-1587-02023-01-30C16284748780-1f386c649-aee5-0266-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
50090-1587-0mupirocin22 g in 1 TUBEOINTMENT2210
50090-1587-0mupirocin1 in 1 CARTONOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1587-0GM - Gram50090-1587f15678ba-21c9-4914-a86f-4bffde6daff412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1587MUPIROCIN OINTMENT [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240201_a6c22c25-0f02-4c06-bbc2-723a18ecdda8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNa6c22c25-0f02-4c06-bbc2-723a18ecdda810
106346mupirocin 0.02 MG/MG Topical OintmentSCDa6c22c25-0f02-4c06-bbc2-723a18ecdda810
106346mupirocin 2 % Topical OintmentSYa6c22c25-0f02-4c06-bbc2-723a18ecdda810
106346mupirocin 20 MG per GM Topical OintmentSYa6c22c25-0f02-4c06-bbc2-723a18ecdda810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1587-0500901587001 TUBE in 1 CARTON (50090-1587-0) / 22 g in 1 TUBE1 tube2014-12-300000-00-00NoNoCurrent