FDA.reportPublic FDA data

Micafungin

Product NDC
71288-028
11-digit product format
712880028
Labeler code
71288
Product ID
71288-028_9571440f-2c9b-4281-b907-0d53408d744e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA215381
Marketing category
ANDA
Marketing start
2022-09-28
Substance
MICAFUNGIN SODIUM
Active strength
50 mg/5mL
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Micafungin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICAFUNGIN SODIUM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIS1UP79R56
Rxcui861379, 861383

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04f262d4-f446-4cf7-b4fa-28b038cd7ee4Product name720260113
9c331f34-aa42-465c-8abd-4e929fba4e94Product name120250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-028-10Micafungin5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,55
71288-028-11Micafungin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105
71288-028-12Micafungin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-028-10EA - Each71288-028cc8d58e4-4ca9-43a5-b6f2-4e22abddd91c12023-02-06
71288-028-11EA - Each71288-028ede6f11f-b706-4e91-b2c6-dd284bce003112023-02-06
71288-028-12EA - Each71288-028e1184d2f-cb36-4bb7-9949-b8dcbcdf06cb12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-028MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20240823_579ff093-0359-4e0e-a6ea-2b6adac80bf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN579ff093-0359-4e0e-a6ea-2b6adac80bf05
861379micafungin sodium 50 MG InjectionPSN579ff093-0359-4e0e-a6ea-2b6adac80bf05
861383micafungin 100 MG InjectionSCD579ff093-0359-4e0e-a6ea-2b6adac80bf05
861379micafungin 50 MG InjectionSCD579ff093-0359-4e0e-a6ea-2b6adac80bf05
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY579ff093-0359-4e0e-a6ea-2b6adac80bf05
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY579ff093-0359-4e0e-a6ea-2b6adac80bf05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-028-10712880028105 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-028-117128800281110 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10) 2022-09-280000-00-00NoNoCurrent
71288-028-12712880028121 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10) 2024-11-01NoNoCurrent