NDC 0049-0116

ERAXIS

Anidulafungin

ERAXIS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Anidulafungin.

Product ID0049-0116_3ac66b17-3e99-4e85-bdf3-ee219c10c18d
NDC0049-0116
Product TypeHuman Prescription Drug
Proprietary NameERAXIS
Generic NameAnidulafungin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-02-17
Marketing CategoryNDA / NDA
Application NumberNDA021632
Labeler NameRoerig
Substance NameANIDULAFUNGIN
Active Ingredient Strength100 mg/30mL
Pharm ClassesEchinocandin Antifungal [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0049-0116-28

30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)
Marketing Start Date2006-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0049-0116-28 [00049011628]

ERAXIS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021632
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-02-17

Drug Details

Active Ingredients

IngredientStrength
ANIDULAFUNGIN100 mg/30mL

OpenFDA Data

SPL SET ID:a88d9010-55fb-4a02-baff-042cd27688ea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1804748
  • 1804743
  • 1804750
  • 1804746
  • Pharmacological Class

    • Echinocandin Antifungal [EPC]
    • Lipopeptides [CS]
    • Echinocandin Antifungal [EPC]
    • Lipopeptides [CS]

    NDC Crossover Matching brand name "ERAXIS" or generic name "Anidulafungin"

    NDCBrand NameGeneric Name
    0049-0114ERAXISanidulafungin
    0049-0116ERAXISanidulafungin

    Trademark Results [ERAXIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ERAXIS
    ERAXIS
    78866502 3791608 Dead/Cancelled
    VICURON HOLDINGS LLC
    2006-04-21
    ERAXIS
    ERAXIS
    78730930 3277483 Live/Registered
    VICURON HOLDINGS LLC
    2005-10-11
    ERAXIS
    ERAXIS
    78233491 not registered Dead/Abandoned
    Vicuron Pharmaceuticals Inc.
    2003-04-03

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