FDA.reportPublic FDA data

Mupirocin

Product NDC
70166-355
11-digit product format
701660355
Labeler code
70166
Product ID
70166-355_313090ef-ad58-1103-e063-6394a90a7d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lohxa
Application
ANDA065170
Marketing category
ANDA
Marketing start
2018-05-26
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
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
70166-355-102025-03-25C16284748780-1f386c649-fce2-0266-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
70166-355-102023-01-30C16284748780-1f386c649-fce2-0266-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
70166-355-10Mupirocin100 in 1 CARTONOINTMENT1003
70166-355-10Mupirocin1 g in 1 TUBEOINTMENT13
70166-355-50Mupirocin1 g in 1 TUBEOINTMENT13
70166-355-50Mupirocin50 in 1 CARTONOINTMENT503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70166-355-10GM - Gram70166-355e96be96d-5540-4ed1-a682-a9e70815ed0b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-355MUPIROCIN OINTMENT [LOHXA]3Current NDC, Legacy NDC, 4 package rows20250327_6d59e35c-b262-7940-e053-2991aa0a8908.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN6d59e35c-b262-7940-e053-2991aa0a89083
106346mupirocin 0.02 MG/MG Topical OintmentSCD6d59e35c-b262-7940-e053-2991aa0a89083
106346mupirocin 2 % Topical OintmentSY6d59e35c-b262-7940-e053-2991aa0a89083
106346mupirocin 20 MG per GM Topical OintmentSY6d59e35c-b262-7940-e053-2991aa0a89083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70166-355-1070166035510100 TUBE in 1 CARTON (70166-355-10) / 1 g in 1 TUBE100 tube2018-05-260000-00-00NoNoCurrent
70166-355-507016603555050 TUBE in 1 CARTON (70166-355-50) / 1 g in 1 TUBE50 tube2025-03-25NoNoHistorical