FDA.reportPublic FDA data

Mupirocin

Product NDC
21922-029
11-digit product format
219220029
Labeler code
21922
Product ID
21922-029_245cc065-74d4-4232-bd0c-f1854a2559c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA213076
Marketing category
ANDA
Marketing start
2021-09-02
Substance
MUPIROCIN CALCIUM
Active strength
2 g/100g
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 CALCIUM2 g/100g

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
21922-029-04Mupirocin1 in 1 CARTONCREAM13
21922-029-04Mupirocin15 g in 1 TUBECREAM153
21922-029-05Mupirocin30 g in 1 TUBECREAM303
21922-029-05Mupirocin1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-029-04GM - Gram21922-029c04be48e-3c68-4734-b52b-5d47f564f7ca12021-10-08
21922-029-05GM - Gram21922-029176e71de-f853-469f-9b8e-4720cd7f199b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-029MUPIROCIN CREAM [ENCUBE ETHICALS PRIVATE LIMITED]2Current NDC, Legacy NDC, 4 package rows20231109_cb085bdf-e371-6e8a-e053-2995a90ae358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSNcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 20 MG/ML Topical CreamSCDcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSYcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 2 % Topical CreamSYcb085bdf-e371-6e8a-e053-2995a90ae3583
311877mupirocin 2 % Topical CreamPSNe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin 20 MG/ML Topical CreamSCDe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSYe250adda-52a5-486f-a43d-2cc486dbe2a81
311877mupirocin 2 % Topical CreamSYe250adda-52a5-486f-a43d-2cc486dbe2a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-029-04219220029041 TUBE in 1 CARTON (21922-029-04) / 15 g in 1 TUBE1 tube2021-09-020000-00-00NoNoCurrent
21922-029-05219220029051 TUBE in 1 CARTON (21922-029-05) / 30 g in 1 TUBE1 tube2021-09-020000-00-00NoNoCurrent