FDA.reportPublic FDA data

mupirocin

Product NDC
68071-4789
11-digit product format
680714789
Labeler code
68071
Product ID
68071-4789_1adc263e-eb1e-53b8-e063-6394a90a9fbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-4789-22024-06-14C16284748780-1ba0f9c33-4024-a910-e053-dadaa90a0b85These 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
68071-4789-22023-01-30C16284748780-1ba0f9c33-4024-a910-e053-dadaa90a0b85These 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
68071-4789-22021-02-17C16284748780-1ba0f9c33-4024-a910-e053-dadaa90a0b85These 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
68071-4789-22021-01-29C16284748780-1ba0f9c33-4024-a910-e053-dadaa90a0b85These 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
68071-4789-2mupirocin22 g in 1 BOXOINTMENT223

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4789MUPIROCIN OINTMENT [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240616_831060e6-17ef-b0a0-e053-2991aa0aeb4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN831060e6-17ef-b0a0-e053-2991aa0aeb4f3
106346mupirocin 0.02 MG/MG Topical OintmentSCD831060e6-17ef-b0a0-e053-2991aa0aeb4f3
106346mupirocin 2 % Topical OintmentSY831060e6-17ef-b0a0-e053-2991aa0aeb4f3
106346mupirocin 20 MG per GM Topical OintmentSY831060e6-17ef-b0a0-e053-2991aa0aeb4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4789-26807147890222 g in 1 BOX (68071-4789-2) 22 g2019-03-010000-00-00NoNoCurrent