NDC 58463-010

Decadron

Dexamethasone

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

Product ID58463-010_37d88d4d-264c-4104-98a4-f4e00013799e
NDC58463-010
Product TypeHuman Prescription Drug
Proprietary NameDecadron
Generic NameDexamethasone
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2018-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA090891
Labeler NamePragma Pharmaceuticals, LLC
Substance NameDEXAMETHASONE
Active Ingredient Strength1 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58463-010-08

237 mL in 1 BOTTLE (58463-010-08)
Marketing Start Date2018-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58463-010-08 [58463001008]

Decadron ELIXIR
Marketing CategoryANDA
Application NumberANDA090891
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE.5 mg/5mL

OpenFDA Data

SPL SET ID:37a5bdfd-67ab-4ea3-862b-35ac30dfd7f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309686
  • 755976
    • UPC Code
  • 0358463010082

    • Pharmacological Class

    • 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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