NDC 0469-3250

Mycamine

Micafungin Sodium

Mycamine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Micafungin Sodium.

Product ID0469-3250_3288a77d-441a-4db5-9759-30f228343a07
NDC0469-3250
Product TypeHuman Prescription Drug
Proprietary NameMycamine
Generic NameMicafungin Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-01
Marketing CategoryNDA / NDA
Application NumberNDA021506
Labeler NameAstellas Pharma US, Inc.
Substance NameMICAFUNGIN SODIUM
Active Ingredient Strength10 mg/mL
Pharm ClassesEchinocandin Antifungal [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0469-3250-50

10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-50) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0469-3250-50 [00469325050]

Mycamine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-01

NDC 0469-3250-10 [00469325010]

Mycamine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-16

Drug Details

Active Ingredients

IngredientStrength
MICAFUNGIN SODIUM10 mg/mL

OpenFDA Data

SPL SET ID:a064c4a7-25ec-4a2c-afc2-703491a4a38b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861385
  • 861379
  • 861381
  • 861383
  • Pharmacological Class

    • Echinocandin Antifungal [EPC]
    • Lipopeptides [CS]

    NDC Crossover Matching brand name "Mycamine" or generic name "Micafungin Sodium"

    NDCBrand NameGeneric Name
    0469-3211MycamineMicafungin Sodium
    0469-3250MycamineMicafungin Sodium
    0143-9361MicafunginMicafungin sodium
    0143-9362MicafunginMicafungin sodium
    25021-190MicafunginMicafungin Sodium
    25021-191MicafunginMicafungin Sodium
    63323-728MicafunginMicafungin Sodium
    63323-729MicafunginMicafungin Sodium
    70594-036MicafunginMicafungin Sodium
    70594-037MicafunginMicafungin Sodium
    71288-028MicafunginMicafungin sodium
    71288-029MicafunginMicafungin sodium
    72572-427MicafunginMicafungin sodium

    Trademark Results [Mycamine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYCAMINE
    MYCAMINE
    76596125 3060777 Live/Registered
    ASTELLAS PHARMA INC.
    2004-06-08
    MYCAMINE
    MYCAMINE
    76215925 not registered Dead/Abandoned
    Fujisawa Pharmaceutical Co., Ltd.
    2001-02-26

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