Pirnuo

Product NDC
68462-560
11-digit product format
684620560
Labeler code
68462
Product ID
68462-560_dc6f3960-2e28-46f1-8619-de5aee5f97ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mupirocin
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA201587
Marketing category
ANDA
Marketing start
2017-07-29
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
Pirnuo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MUPIROCIN CALCIUM2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG38I2P540
Rxcui311877, 2286614

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
68462-560-47Pirnuo1 in 1 CARTONCREAM12
68462-560-47Pirnuo42.5 g in 1 BOTTLECREAM42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-560PIRNUO (MUPIROCIN) CREAM [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, Legacy NDC, 2 package rows20240104_89c43f7b-1a88-45bf-a356-07518d4e7870.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311877mupirocin 2 % Topical CreamPSN89c43f7b-1a88-45bf-a356-07518d4e78702
2286614PIRNUO 2 % Topical CreamPSN89c43f7b-1a88-45bf-a356-07518d4e78702
2286614mupirocin 20 MG/ML Topical Cream [Pirnuo]SBD89c43f7b-1a88-45bf-a356-07518d4e78702
311877mupirocin 20 MG/ML Topical CreamSCD89c43f7b-1a88-45bf-a356-07518d4e78702
311877mupirocin (as mupirocin calcium) 20 MG/ML Topical CreamSY89c43f7b-1a88-45bf-a356-07518d4e78702
311877mupirocin 2 % Topical CreamSY89c43f7b-1a88-45bf-a356-07518d4e78702
2286614Pirnuo 2 % Topical CreamSY89c43f7b-1a88-45bf-a356-07518d4e78702
2286614Pirnuo 20 MG/ML Topical CreamSY89c43f7b-1a88-45bf-a356-07518d4e78702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-560-47684620560471 BOTTLE in 1 CARTON (68462-560-47) / 42.5 g in 1 BOTTLE1 bottle2019-07-290000-00-00NoNoCurrent