FDA.reportPublic FDA data

Mupirocin

Product NDC
68387-550
11-digit product format
683870550
Labeler code
68387
Product ID
68387-550_dacd7084-7ed1-4371-91ea-c797f4636afa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA065192
Marketing category
ANDA
Marketing start
2009-06-22
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
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
68387-550-012019-10-29C16284748780-1960f7f55-d46c-8e05-e053-dbdaa90a074aMUPIROCIN OINTMENT USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-550-01Mupirocin22 g in 1 TUBEOINTMENT221
68387-550-01Mupirocin1 in 1 BAGOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-550-01GM - Gram68387-5503865c145-57e4-47ae-aa68-684eab325b1312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MUPIROCINACTIVE INGREDIENTD0GX863OA5MUPIROCIN OINTMENT [KELTMAN PHARMACEUTICALS INC.]1
mupirocinACTIVE MOIETYD0GX863OA5MUPIROCIN OINTMENT [KELTMAN PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMUPIROCIN OINTMENT [KELTMAN PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMUPIROCIN OINTMENT [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-550MUPIROCIN OINTMENT [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20110712_c624575e-558c-4cfd-b1e0-c262ed11cff9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNc624575e-558c-4cfd-b1e0-c262ed11cff91
106346mupirocin 0.02 MG/MG Topical OintmentSCDc624575e-558c-4cfd-b1e0-c262ed11cff91
106346mupirocin 2 % Topical OintmentSYc624575e-558c-4cfd-b1e0-c262ed11cff91
106346mupirocin 20 MG per GM Topical OintmentSYc624575e-558c-4cfd-b1e0-c262ed11cff91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68387-550-016838705500122 g in 1 TUBE22 gHistorical