FDA.reportPublic FDA data

Micafungin

Product NDC
42023-229
11-digit product format
420230229
Labeler code
42023
Product ID
42023-229_9e300655-e1cc-4f04-9a9e-9b81688368dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA212156
Marketing category
NDA
Marketing start
2021-08-01
Substance
MICAFUNGIN SODIUM
Active strength
10 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 SODIUM10 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-229-10Micafungin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1013
42023-229-10Micafungin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-229-10EA - Each42023-2297c3b9862-5669-49e9-bf00-874c60d4262412021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-229MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]11Current NDC, Legacy NDC, 2 package rows20240915_70b3f044-95ca-4503-b669-ed39972592b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN70b3f044-95ca-4503-b669-ed39972592b613
861379micafungin sodium 50 MG InjectionPSN70b3f044-95ca-4503-b669-ed39972592b613
861383micafungin 100 MG InjectionSCD70b3f044-95ca-4503-b669-ed39972592b613
861379micafungin 50 MG InjectionSCD70b3f044-95ca-4503-b669-ed39972592b613
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY70b3f044-95ca-4503-b669-ed39972592b613
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY70b3f044-95ca-4503-b669-ed39972592b613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42023-229-104202302291010 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) / 10 mL in 1 VIAL, SINGLE-DOSE2021-08-010000-00-00NoNoCurrent