FDA.reportPublic FDA data

MUPIROCIN

Product NDC
61919-407
11-digit product format
619190407
Labeler code
61919
Product ID
61919-407_ead3ddea-22e9-419e-bff2-99b13561e0e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MUPIROCIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
DirectRX
Application
ANDA090480
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-407-222020-01-31C16284748780-19d75b9d0-7fc0-f424-e053-dadaa90a57ceMUPIROCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-407-22MUPIROCIN2%22 g in 1 TUBEOINTMENT221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-407-22GM - Gram61919-40763e4fb54-6484-4aec-b123-3db26d3dfc4312016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MUPIROCINACTIVE INGREDIENTD0GX863OA5MUPIROCIN 2% (MUPIROCIN) OINTMENT [DIRECTRX]1
MUPIROCINACTIVE MOIETYD0GX863OA5MUPIROCIN 2% (MUPIROCIN) OINTMENT [DIRECTRX]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMUPIROCIN 2% (MUPIROCIN) OINTMENT [DIRECTRX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMUPIROCIN 2% (MUPIROCIN) OINTMENT [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-407MUPIROCIN 2% (MUPIROCIN) OINTMENT [DIRECTRX]1Legacy NDC, 1 package rows20151116_3c4accb1-749d-4b89-bec5-5b9b7ea9dd23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSN3c4accb1-749d-4b89-bec5-5b9b7ea9dd231
106346mupirocin 0.02 MG/MG Topical OintmentSCD3c4accb1-749d-4b89-bec5-5b9b7ea9dd231
106346mupirocin 2 % Topical OintmentSY3c4accb1-749d-4b89-bec5-5b9b7ea9dd231
106346mupirocin 20 MG per GM Topical OintmentSY3c4accb1-749d-4b89-bec5-5b9b7ea9dd231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-407-226191904072222 g in 1 TUBE22 gHistorical