NDC 42998-502

EMFLAZA

Deflazacort

EMFLAZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marathon Pharmaceuticals, Llc. The primary component is Deflazacort.

Product ID42998-502_4e001bac-ce04-4262-96f4-8b23161f9e55
NDC42998-502
Product TypeHuman Prescription Drug
Proprietary NameEMFLAZA
Generic NameDeflazacort
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-09
Marketing End Date2020-06-30
Marketing CategoryNDA / NDA
Application NumberNDA208684
Labeler NameMarathon Pharmaceuticals, LLC
Substance NameDEFLAZACORT
Active Ingredient Strength18 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 42998-502-03

30 TABLET in 1 BOTTLE (42998-502-03)
Marketing Start Date2017-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42998-502-03 [42998050203]

EMFLAZA TABLET
Marketing CategoryNDA
Application NumberNDA208684
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-09
Marketing End Date2020-06-30

Drug Details

Active Ingredients

IngredientStrength
DEFLAZACORT18 mg/1

OpenFDA Data

SPL SET ID:c1d8a24e-96d4-4e3a-8f7e-b9c2dc060b1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1870964
  • 1870960
  • 153880
  • 1870968
  • 1870958
  • 1870956
  • 1870954
  • 1870952
  • 153098
  • 1870950
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "EMFLAZA" or generic name "Deflazacort"

    NDCBrand NameGeneric Name
    42998-501EMFLAZAdeflazacort
    42998-502EMFLAZAdeflazacort
    42998-503EMFLAZAdeflazacort
    42998-504EMFLAZAdeflazacort
    42998-505EMFLAZAdeflazacort
    52856-501EMFLAZAdeflazacort
    52856-502EMFLAZAdeflazacort
    52856-503EMFLAZAdeflazacort
    52856-504EMFLAZAdeflazacort
    52856-505EMFLAZAdeflazacort

    Trademark Results [EMFLAZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EMFLAZA
    EMFLAZA
    86639624 5261599 Live/Registered
    PTC THERAPEUTICS, INC.
    2015-05-22

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