FDA.reportPublic FDA data

Micafungin in Sodium Chloride

Product NDC
0338-9051
11-digit product format
003389051
Labeler code
0338
Product ID
0338-9051_c4a06712-4236-4c33-b5ae-77db633e8303
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA216142
Marketing category
NDA
Marketing start
2023-09-29
Substance
MICAFUNGIN SODIUM
Active strength
50 mg/50mL
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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICAFUNGIN SODIUM50 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIS1UP79R56
Rxcui2667650, 2667652, 2667653

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
0338-9051-01Micafungin in Sodium Chloride1 in 1 CARTONINJECTION14
0338-9051-01Micafungin in Sodium Chloride50 mL in 1 BAGINJECTION504
0338-9051-12Micafungin in Sodium Chloride12 in 1 CARTONINJECTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9051-01ML - Milliliter0338-90516018d3a1-a870-4294-93dd-74c1934d520b12024-06-10
0338-9051-12ML - Milliliter0338-905129177c7b-0f27-463d-b102-a488d39b1cae12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9051MICAFUNGIN IN SODIUM CHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, 3 package rows20250501_a95f901e-0ac4-4ec0-9720-9c6a066cd06c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667650micafungin 100 MG in 100 ML InjectionPSNa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667652micafungin 150 MG in 150 ML InjectionPSNa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667653micafungin 50 MG in 50 ML InjectionPSNa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667650100 ML micafungin 1 MG/ML InjectionSCDa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667652150 ML micafungin 1 MG/ML InjectionSCDa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
266765350 ML micafungin 1 MG/ML InjectionSCDa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667650micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) per 100 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667650micafungin 100 MG per 100 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667652micafungin 150 MG (equivalent to micafungin sodium 152.6 MG) per 100 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667652micafungin 150 MG per 150 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667653micafungin 50 MG (equivalent to micafungin sodium 50.87 MG) per 100 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4
2667653micafungin 50 MG per 50 ML InjectionSYa95f901e-0ac4-4ec0-9720-9c6a066cd06c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9051-01003389051011 in 1 CARTONHistorical
0338-9051-120033890511212 CARTON in 1 CARTON (0338-9051-12) / 1 BAG in 1 CARTON (0338-9051-01) / 50 mL in 1 BAG12 carton2023-09-29NoNoHistorical