FDA.reportPublic FDA data

Mupirocin

Product NDC
63187-151
11-digit product format
631870151
Labeler code
63187
Product ID
63187-151_a22d9ce1-ccc1-4955-939c-b74e110cffa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
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

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
63187-151-222019-12-04C16284748780-19855e2a2-4bb4-60a7-e053-dbdaa90a05bdMupirocin Ointment USP, 2%
63187-151-222019-11-27C16284748780-19855e2a2-4bb4-60a7-e053-dbdaa90a05bdMupirocin Ointment USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-151-22Mupirocin1 in 1 CARTONOINTMENT14
63187-151-22Mupirocin22 g in 1 TUBEOINTMENT224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-151-22GM - Gram63187-15112c73070-ca87-4eee-a1c2-a49ab662680412015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MupirocinACTIVE INGREDIENTD0GX863OA5MUPIROCIN OINTMENT [PROFICIENT RX LP]1
MupirocinACTIVE MOIETYD0GX863OA5MUPIROCIN OINTMENT [PROFICIENT RX LP]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PMUPIROCIN OINTMENT [PROFICIENT RX LP]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMUPIROCIN OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-151MUPIROCIN OINTMENT [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20230115_d8766748-6b53-4673-a3ee-5cd8a4301647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106346mupirocin 2 % Topical OintmentPSNd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 0.02 MG/MG Topical OintmentSCDd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 2 % Topical OintmentSYd8766748-6b53-4673-a3ee-5cd8a43016474
106346mupirocin 20 MG per GM Topical OintmentSYd8766748-6b53-4673-a3ee-5cd8a43016474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-151-22631870151221 TUBE in 1 CARTON (63187-151-22) / 22 g in 1 TUBE1 tube2014-09-010000-00-00NoNoCurrent