FDA.reportPublic FDA data

Micafungin

Product NDC
70710-1725
11-digit product format
707101725
Labeler code
70710
Product ID
70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA215241
Marketing category
ANDA
Marketing start
2023-04-10
Substance
MICAFUNGIN SODIUM
Active strength
20 mg/mL
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 SODIUM20 mg/mL

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1725-1Micafungin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,54
70710-1725-1Micafungin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70710-1725-6Micafungin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104
70710-1725-6Micafungin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1725MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, 4 package rows20250121_29f17423-5787-47d0-a83b-bbdc0198fbfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN29f17423-5787-47d0-a83b-bbdc0198fbfa4
861379micafungin sodium 50 MG InjectionPSN29f17423-5787-47d0-a83b-bbdc0198fbfa4
861383micafungin 100 MG InjectionSCD29f17423-5787-47d0-a83b-bbdc0198fbfa4
861379micafungin 50 MG InjectionSCD29f17423-5787-47d0-a83b-bbdc0198fbfa4
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY29f17423-5787-47d0-a83b-bbdc0198fbfa4
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY29f17423-5787-47d0-a83b-bbdc0198fbfa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1725-1707101725011 VIAL in 1 CARTON (70710-1725-1) / 5 mL in 1 VIAL1 vial2024-08-20NoNoCurrent
70710-1725-67071017250610 VIAL in 1 CARTON (70710-1725-6) / 5 mL in 1 VIAL10 vial2023-04-10NoNoCurrent