NDC 52856-501

EMFLAZA

Deflazacort

EMFLAZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ptc Therapeutics, Inc.. The primary component is Deflazacort.

Product ID52856-501_093eae66-8239-47c7-8cc7-9b4be164fb70
NDC52856-501
Product TypeHuman Prescription Drug
Proprietary NameEMFLAZA
Generic NameDeflazacort
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-10
Marketing CategoryNDA / NDA
Application NumberNDA208684
Labeler NamePTC Therapeutics, Inc.
Substance NameDEFLAZACORT
Active Ingredient Strength6 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 52856-501-01

100 TABLET in 1 BOTTLE (52856-501-01)
Marketing Start Date2018-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52856-501-01 [52856050101]

EMFLAZA TABLET
Marketing CategoryNDA
Application NumberNDA208684
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-10

Drug Details

Active Ingredients

IngredientStrength
DEFLAZACORT6 mg/1

OpenFDA Data

SPL SET ID:31b347d2-f156-4055-9d8f-7cf0df420296
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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