FDA.reportPublic FDA data

Micafungin

Product NDC
63323-728
11-digit product format
633230728
Labeler code
63323
Product ID
63323-728_e9aa7e59-831f-4994-802b-b62221fdfca3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA207344
Marketing category
ANDA
Marketing start
2020-05-08
Substance
MICAFUNGIN SODIUM
Active strength
50 mg/1
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/1

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
63323-728-01Micafungin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,17
63323-728-01Micafungin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
63323-728-10Micafungin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-728-01EA - Each63323-7289afa7911-96ef-46a4-9e8f-58ae3b21a95312020-05-08
63323-728-10EA - Each63323-7280d2c5249-16ba-4f96-8551-b722c2be492c12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-728MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 3 package rows20241022_dc5241be-4b85-4f04-8553-9819603373b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSNdc5241be-4b85-4f04-8553-9819603373b87
861379micafungin sodium 50 MG InjectionPSNdc5241be-4b85-4f04-8553-9819603373b87
861383micafungin 100 MG InjectionSCDdc5241be-4b85-4f04-8553-9819603373b87
861379micafungin 50 MG InjectionSCDdc5241be-4b85-4f04-8553-9819603373b87
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSYdc5241be-4b85-4f04-8553-9819603373b87
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSYdc5241be-4b85-4f04-8553-9819603373b87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-728-01633230728011 in 1 VIAL, SINGLE-DOSEHistorical
63323-728-106332307281010 CARTON in 1 CARTON (63323-728-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-728-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE10 carton2020-05-080000-00-00NoNoCurrent