FDA.reportPublic FDA data

Micafungin

Product NDC
0143-9361
11-digit product format
001439361
Labeler code
0143
Product ID
0143-9361_b73ed270-efe6-45d7-949c-b175415a9b5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213261
Marketing category
ANDA
Marketing start
2021-07-09
Substance
MICAFUNGIN
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
MICAFUNGIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR10H71BSWG
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
0143-9361-01Micafungin5 in 1 VIALINJECTION, POWDER, LYOPHILIZED,56
0143-9361-01Micafungin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9361-01EA - Each0143-936119c86f3b-103f-4832-91ff-9e85c79a432512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9361MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240808_8ba6f80c-05f0-4d75-930c-c8458db2e1c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN8ba6f80c-05f0-4d75-930c-c8458db2e1c16
861379micafungin sodium 50 MG InjectionPSN8ba6f80c-05f0-4d75-930c-c8458db2e1c16
861383micafungin 100 MG InjectionSCD8ba6f80c-05f0-4d75-930c-c8458db2e1c16
861379micafungin 50 MG InjectionSCD8ba6f80c-05f0-4d75-930c-c8458db2e1c16
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY8ba6f80c-05f0-4d75-930c-c8458db2e1c16
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY8ba6f80c-05f0-4d75-930c-c8458db2e1c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9361-01001439361011 VIAL in 1 CARTON (0143-9361-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2021-07-090000-00-00NoNoCurrent