NDC 70569-151

Dxevo

Dexamethasone

Dxevo is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Phlight Pharma, Llc. The primary component is Dexamethasone.

Product ID70569-151_8baea07b-6071-3742-e053-2a95a90acd82
NDC70569-151
Product TypeHuman Prescription Drug
Proprietary NameDxevo
Generic NameDexamethasone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA201270
Labeler NamePhlight Pharma, LLC
Substance NameDEXAMETHASONE
Active Ingredient Strength2 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70569-151-11

39 TABLET in 1 DOSE PACK (70569-151-11)
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70569-151-11 [70569015111]

Dxevo TABLET
Marketing CategoryANDA
Application NumberANDA201270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-17

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1.5 mg/1

OpenFDA Data

SPL SET ID:e362f596-dad7-4793-a6e6-bf05a742f449
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197580
  • 2121587
  • 2121735

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    70362-707DxevoDxevo
    70362-702DxevoDxevo
    70569-151DxevoDxevo
    0054-3177DexamethasoneDexamethasone
    0054-4179DexamethasoneDexamethasone
    0054-4180DexamethasoneDexamethasone
    0054-4181DexamethasoneDexamethasone
    0054-4182DexamethasoneDexamethasone
    0054-4183DexamethasoneDexamethasone
    0054-4184DexamethasoneDexamethasone
    0054-4186DexamethasoneDexamethasone
    0054-8174DexamethasoneDexamethasone
    0023-3348OZURDEXdexamethasone

    Trademark Results [Dxevo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DXEVO
    DXEVO
    88334412 not registered Live/Pending
    LARKEN LABORATORIES, INC.
    2019-03-11
    DXEVO
    DXEVO
    88245240 not registered Live/Pending
    Innovate Research & Development, LLC
    2018-12-29
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