NDC 58463-016

Decadron

Dexamethasone

Decadron is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pragma Pharmaceuticals, Llc. The primary component is Dexamethasone.

Product ID58463-016_2f2e5809-635f-4b7f-81d3-71493f46895a
NDC58463-016
Product TypeHuman Prescription Drug
Proprietary NameDecadron
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-02-28
Marketing End Date2022-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA088481
Labeler NamePragma Pharmaceuticals, LLC
Substance NameDEXAMETHASONE
Active Ingredient Strength4 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 58463-016-01

100 TABLET in 1 BOTTLE (58463-016-01)
Marketing Start Date2018-02-28
Marketing End Date2022-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58463-016-01 [58463001601]

Decadron TABLET
Marketing CategoryANDA
Application NumberANDA088481
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE4 mg/1

OpenFDA Data

SPL SET ID:f8d52954-be1d-45d3-9245-ff2e3e81a8ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 343033
  • 197582
  • 197583
  • 343040
  • 197577
  • 105392
  • 205712
  • 205717
  • UPC Code
  • 0358463015018
  • 0358463014011
  • 0358463016015
  • 0358463017012
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Decadron" or generic name "Dexamethasone"

    NDCBrand NameGeneric Name
    58463-016DecadronDecadron
    58463-017DecadronDecadron
    58463-014DecadronDecadron
    58463-015DecadronDecadron
    58463-010DecadronDecadron
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    0023-3348OZURDEXdexamethasone

    Trademark Results [Decadron]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DECADRON
    DECADRON
    86259295 4993855 Live/Registered
    Pragma Pharmaceuticals
    2014-04-22
    DECADRON
    DECADRON
    85599666 not registered Dead/Abandoned
    Medimetriks Pharmaceuticals, Inc.
    2012-04-17
    DECADRON
    DECADRON
    77860672 not registered Dead/Abandoned
    Fera Pharmaceuticals, LLC
    2009-10-29
    DECADRON
    DECADRON
    72052322 0673426 Dead/Expired
    MERCK & CO., INC.
    1958-05-26

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