FDA.reportPublic FDA data

Mupirocin

Product NDC
68071-4321
11-digit product format
680714321
Labeler code
68071
Product ID
68071-4321_1a3dc88f-20df-241c-e063-6294a90aa423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065170
Marketing category
ANDA
Marketing start
2005-09-23
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
68071-4321-22023-11-14C16284748780-1ba0f9c33-110a-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
68071-4321-22023-01-30C16284748780-1ba0f9c33-110a-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
68071-4321-22021-02-16C16284748780-1ba0f9c33-110a-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
68071-4321-22021-01-29C16284748780-1ba0f9c33-110a-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
68071-4321-2Mupirocin22 g in 1 BOXOINTMENT226

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4321MUPIROCIN OINTMENT [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20240608_66db1071-024f-aa19-e053-2a91aa0a8e39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN66db1071-024f-aa19-e053-2a91aa0a8e396
106346mupirocin 0.02 MG/MG Topical OintmentSCD66db1071-024f-aa19-e053-2a91aa0a8e396
106346mupirocin 2 % Topical OintmentSY66db1071-024f-aa19-e053-2a91aa0a8e396
106346mupirocin 20 MG per GM Topical OintmentSY66db1071-024f-aa19-e053-2a91aa0a8e396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4321-26807143210222 g in 1 BOX (68071-4321-2) 22 g2018-03-070000-00-00NoNoCurrent