NDC 0078-0650

FARYDAK

Panobinostat

FARYDAK is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Panobinostat Lactate.

Product ID0078-0650_1de1e12a-af22-4b99-9116-585bcfc1e304
NDC0078-0650
Product TypeHuman Prescription Drug
Proprietary NameFARYDAK
Generic NamePanobinostat
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-02-23
Marketing End Date2021-02-28
Marketing CategoryNDA / NDA
Application NumberNDA205353
Labeler NameNovartis Pharmaceuticals Corporation
Substance NamePANOBINOSTAT LACTATE
Active Ingredient Strength10 mg/1
Pharm ClassesHistone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0078-0650-06

6 CAPSULE in 1 BLISTER PACK (0078-0650-06)
Marketing Start Date2015-02-23
Marketing End Date2023-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0650-06 [00078065006]

FARYDAK CAPSULE
Marketing CategoryNDA
Application NumberNDA205353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-23
Marketing End Date2023-01-31

Drug Details

Active Ingredients

IngredientStrength
PANOBINOSTAT LACTATE10 mg/1

OpenFDA Data

SPL SET ID:7774972a-eeaa-4b9a-9e56-3fc1b968e86a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1603361
  • 1603363
  • 1603365
  • 1603367
  • 1603355
  • 1603369
  • Pharmacological Class

    • Histone Deacetylase Inhibitor [EPC]
    • Histone Deacetylase Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]

    NDC Crossover Matching brand name "FARYDAK" or generic name "Panobinostat"

    NDCBrand NameGeneric Name
    0078-0650FARYDAKpanobinostat
    0078-0651FARYDAKpanobinostat
    0078-0652FARYDAKpanobinostat
    73116-100FARYDAKpanobinostat
    73116-101FARYDAKpanobinostat
    73116-102FARYDAKpanobinostat

    Trademark Results [FARYDAK]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FARYDAK
    FARYDAK
    86140638 4765286 Live/Registered
    SECURA BIO, INC.
    2013-12-11
    FARYDAK
    FARYDAK
    79050673 3502071 Live/Registered
    Secura Bio, Inc.
    2008-02-01

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