NDC 0085-4324

NOXAFIL

Posaconazole

NOXAFIL is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Posaconazole.

Product ID0085-4324_125b529c-3a8d-4672-8264-da4834fabe79
NDC0085-4324
Product TypeHuman Prescription Drug
Proprietary NameNOXAFIL
Generic NamePosaconazole
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-11-25
Marketing CategoryNDA / NDA
Application NumberNDA205053
Labeler NameMerck Sharp & Dohme Corp.
Substance NamePOSACONAZOLE
Active Ingredient Strength100 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0085-4324-02

60 TABLET, COATED in 1 BOTTLE (0085-4324-02)
Marketing Start Date2013-11-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-4324-02 [00085432402]

NOXAFIL TABLET, COATED
Marketing CategoryNDA
Application NumberNDA205053
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-11-25

Drug Details

Active Ingredients

IngredientStrength
POSACONAZOLE100 mg/1

OpenFDA Data

SPL SET ID:b073b082-7b57-4423-8c06-4fd4263d6f84
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 665022
  • 665019
  • 1492043
  • 1492047
  • 1482908
  • 1482912
  • UPC Code
  • 0300854324025
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "NOXAFIL" or generic name "Posaconazole"

    NDCBrand NameGeneric Name
    0085-1328NOXAFILposaconazole
    0085-2224NOXAFILposaconazole
    0085-4324NOXAFILposaconazole
    0085-4331NOXAFILposaconazole
    0254-2045POSACONAZOLEposaconazole
    0406-7711POSACONAZOLEposaconazole
    0527-2133POSACONAZOLEPosaconazole

    Trademark Results [NOXAFIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOXAFIL
    NOXAFIL
    77007334 3825429 Live/Registered
    MERCK SHARP & DOHME CORP.
    2006-09-25
    NOXAFIL
    NOXAFIL
    75731165 2468349 Live/Registered
    MERCK SHARP & DOHME CORP.
    1999-06-17
    NOXAFIL
    NOXAFIL
    75217327 not registered Dead/Abandoned
    SCHERING CORPORATION
    1996-12-23

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