FDA.reportPublic FDA data

MUPIROCIN

Product NDC
46708-624
11-digit product format
467080624
Labeler code
46708
Product ID
46708-624_9c983738-f481-4e39-b812-69b45c7e9401
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MUPIROCIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213053
Marketing category
ANDA
Marketing start
2025-03-18
Substance
MUPIROCIN CALCIUM
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
MUPIROCIN CALCIUM20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG38I2P540
Rxcui311877

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-624-15MUPIROCIN1 in 1 CARTONCREAM11
46708-624-15MUPIROCIN15 g in 1 TUBECREAM151
46708-624-30MUPIROCIN30 g in 1 TUBECREAM301
46708-624-30MUPIROCIN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-624MUPIROCIN CREAM [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250321_0580458d-7178-4031-8ac7-0cda281ade8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSN0580458d-7178-4031-8ac7-0cda281ade8b1
311877mupirocin 20 MG/ML Topical CreamSCD0580458d-7178-4031-8ac7-0cda281ade8b1
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSY0580458d-7178-4031-8ac7-0cda281ade8b1
311877mupirocin 2 % Topical CreamSY0580458d-7178-4031-8ac7-0cda281ade8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-624-15467080624151 TUBE in 1 CARTON (46708-624-15) / 15 g in 1 TUBE1 tube2025-03-18NoNoHistorical
46708-624-30467080624301 TUBE in 1 CARTON (46708-624-30) / 30 g in 1 TUBE1 tube2025-03-18NoNoHistorical