FDA.reportPublic FDA data

Micafungin

Product NDC
42658-022
11-digit product format
426580022
Labeler code
42658
Product ID
42658-022_4f4d74bd-7d4e-0340-e063-6394a90aee8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hisun Pharmaceuticals USA, Inc.
Application
ANDA219712
Marketing category
ANDA
Marketing start
2026-04-01
Substance
MICAFUNGIN SODIUM
Active strength
50 mg/1
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Micafungin
Listing expiration
2027-12-31

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
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
42658-022-01Micafungin1 in 1 BOXINJECTION, POWDER, FOR SOLUTION16
42658-022-01Micafungin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
42658-022-02Micafungin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
42658-022-02Micafungin1 in 1 BOXINJECTION, POWDER, FOR SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42658-022-01EA - Each42658-022d4a25724-e95f-4bf3-90fe-8d74d76aaf0b12026-04-20
42658-022-02EA - Each42658-0224ec27adc-6103-4198-9260-10bb77441b7112026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin sodium 50 MG InjectionPSN230fcff4-ad4b-ea25-e063-6394a90a1fab6
861383micafungin 100 MG InjectionSCD230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin 50 MG InjectionSCD230fcff4-ad4b-ea25-e063-6394a90a1fab6
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY230fcff4-ad4b-ea25-e063-6394a90a1fab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42658-022-01426580022011 VIAL in 1 BOX (42658-022-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2026-04-01NoNoHistorical
42658-022-024265800220210 BOX in 1 CARTON (42658-022-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 box2026-04-01NoNoHistorical