NDC 76014-005

Akovaz

Ephedrine Sulfate

Akovaz is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Avadel Legacy Pharmaceuticals, Llc. The primary component is Ephedrine Sulfate.

Product ID76014-005_26f0bc51-fbc5-4d99-9972-6344f51f64a6
NDC76014-005
Product TypeHuman Prescription Drug
Proprietary NameAkovaz
Generic NameEphedrine Sulfate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-08-01
Marketing End Date2023-09-30
Marketing CategoryNDA / NDA
Application NumberNDA208289
Labeler NameAvadel Legacy Pharmaceuticals, LLC
Substance NameEPHEDRINE SULFATE
Active Ingredient Strength50 mg/mL
Pharm Classesalpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]
NDC Exclude FlagN

Packaging

NDC 76014-005-25

25 VIAL, SINGLE-DOSE in 1 CARTON (76014-005-25) > 1 mL in 1 VIAL, SINGLE-DOSE (76014-005-30)
Marketing Start Date2016-08-01
Marketing End Date2023-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76014-005-30 [76014000530]

Akovaz INJECTION
Marketing CategoryNDA
Application NumberNDA208289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-01

NDC 76014-005-25 [76014000525]

Akovaz INJECTION
Marketing CategoryNDA
Application NumberNDA208289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-01

Drug Details

Active Ingredients

IngredientStrength
EPHEDRINE SULFATE50 mg/mL

OpenFDA Data

SPL SET ID:25828db2-4942-4f7c-a0d5-dc66f82cfb71
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796730
  • 1116294
    • UPC Code
  • 0376014005301
  • 0376014005257

    • Pharmacological Class

    • alpha-Adrenergic Agonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • beta-Adrenergic Agonist [EPC]
    • Adrenergic beta-Agonists [MoA]
    • Norepinephrine Releasing Agent [EPC]
    • Increased Norepinephrine Activity [PE]

    NDC Crossover Matching brand name "Akovaz" or generic name "Ephedrine Sulfate"

    NDCBrand NameGeneric Name
    68001-330AkovazAkovaz
    76014-005AkovazAkovaz
    42023-196CorphedraEphedrine Sulfate
    42023-233Corphedraephedrine sulfate
    14789-250EmerphedEphedrine Sulfate
    0143-3145Ephedrine SulfateEphedrine Sulfate
    0363-5789Ephedrine SulfateEphedrine Sulfate
    0641-6238Ephedrine SulfateEphedrine Sulfate
    0781-3269Ephedrine SulfateEphedrine Sulfate
    14789-014Ephedrine SulfateEphedrine Sulfate
    16714-037Ephedrine SulfateEphedrine Sulfate
    17478-415Ephedrine SulfateEphedrine Sulfate
    17478-515Ephedrine SulfateEphedrine Sulfate
    17478-517Ephedrine SulfateEphedrine Sulfate
    17478-955Ephedrine SulfateEphedrine Sulfate
    42023-216Ephedrine SulfateEphedrine Sulfate
    42023-243EPHEDRINE SULFATEEphedrine Sulfate
    42023-253EPHEDRINE SULFATEEphedrine Sulfate
    43598-725Ephedrine sulfateEphedrine sulfate

    Trademark Results [Akovaz]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AKOVAZ
    AKOVAZ
    86612113 5055498 Live/Registered
    Flamel Ireland Limited
    2015-04-28
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