FDA.reportPublic FDA data

Mupirocin

Product NDC
21695-188
11-digit product format
216950188
Labeler code
21695
Product ID
21695-188_a76947bd-0430-4d79-b4c1-9d1746bc7f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
ANDA065192
Marketing category
ANDA
Marketing start
2005-11-30
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
21695-188-222019-09-24C16284748780-1934fe258-4839-48b1-e053-8cdaa90a720aMUPIROCIN OINTMENT USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-188-22Mupirocin22 g in 1 TUBEOINTMENT221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-188-22GM - Gram21695-1888bffbc34-6c74-4a3a-8142-79285139df3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mupirocinACTIVE INGREDIENTD0GX863OA5MUPIROCIN OINTMENT [REBEL DISTRIBUTORS CORP.]1
mupirocinACTIVE MOIETYD0GX863OA5MUPIROCIN OINTMENT [REBEL DISTRIBUTORS CORP.]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PMUPIROCIN OINTMENT [REBEL DISTRIBUTORS CORP.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMUPIROCIN OINTMENT [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-188MUPIROCIN OINTMENT [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20101123_a76947bd-0430-4d79-b4c1-9d1746bc7f84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNa76947bd-0430-4d79-b4c1-9d1746bc7f841
106346mupirocin 0.02 MG/MG Topical OintmentSCDa76947bd-0430-4d79-b4c1-9d1746bc7f841
106346mupirocin 2 % Topical OintmentSYa76947bd-0430-4d79-b4c1-9d1746bc7f841
106346mupirocin 20 MG per GM Topical OintmentSYa76947bd-0430-4d79-b4c1-9d1746bc7f841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-188-222169501882222 g in 1 TUBE22 gHistorical