FDA.reportPublic FDA data

Mupirocin

Product NDC
51672-1370
11-digit product format
516721370
Labeler code
51672
Product ID
51672-1370_4f1deb92-5055-69e7-e063-6394a90a40bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin Calcium
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207116
Marketing category
ANDA
Marketing start
2020-04-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mupirocin
Listing expiration
2027-12-31

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
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1370-1Mupirocin1 in 1 CARTONCREAM13
51672-1370-1Mupirocin15 g in 1 TUBECREAM153
51672-1370-2Mupirocin1 in 1 CARTONCREAM13
51672-1370-2Mupirocin30 g in 1 TUBECREAM303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1370-1GM - Gram51672-1370b63a98ce-23c7-4b5e-af6b-c6761f7b5e2d12020-05-08
51672-1370-2GM - Gram51672-1370a5f77a9f-3ed3-44b6-b560-2f515359b26a12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1370MUPIROCIN (MUPIROCIN CALCIUM) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 4 package rows20200430_6719ffba-3430-4fa9-b65b-c5c195ee1b35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSN6719ffba-3430-4fa9-b65b-c5c195ee1b353
311877mupirocin 2 % Topical CreamPSN9a1be092-6fe8-4b7c-a668-e584783f888b3
311877mupirocin 20 MG/ML Topical CreamSCD6719ffba-3430-4fa9-b65b-c5c195ee1b353
311877mupirocin 20 MG/ML Topical CreamSCD9a1be092-6fe8-4b7c-a668-e584783f888b3
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSY6719ffba-3430-4fa9-b65b-c5c195ee1b353
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSY9a1be092-6fe8-4b7c-a668-e584783f888b3
311877mupirocin 2 % Topical CreamSY6719ffba-3430-4fa9-b65b-c5c195ee1b353
311877mupirocin 2 % Topical CreamSY9a1be092-6fe8-4b7c-a668-e584783f888b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1370-1516721370011 TUBE in 1 CARTON (51672-1370-1) / 15 g in 1 TUBE1 tube2020-04-270000-00-00NoNoCurrent
51672-1370-2516721370021 TUBE in 1 CARTON (51672-1370-2) / 30 g in 1 TUBE1 tube2020-04-270000-00-00NoNoCurrent