NDC 14335-070

Eptifibatide

Eptifibatide

Eptifibatide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hainan Poly Pharm. Co., Ltd.. The primary component is Eptifibatide.

Product ID14335-070_80b86c46-22e3-0090-e053-2991aa0a8fc1
NDC14335-070
Product TypeHuman Prescription Drug
Proprietary NameEptifibatide
Generic NameEptifibatide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA209864
Labeler NameHainan Poly Pharm. Co., Ltd.
Substance NameEPTIFIBATIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesDecreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 14335-070-01

10 mL in 1 VIAL (14335-070-01)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14335-070-01 [14335007001]

Eptifibatide INJECTION
Marketing CategoryANDA
Application NumberANDA209864
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-22

Drug Details

Active Ingredients

IngredientStrength
EPTIFIBATIDE2 mg/mL

OpenFDA Data

SPL SET ID:80b86c46-230c-0090-e053-2991aa0a8fc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200349
  • 1736470
  • Pharmacological Class

    • Decreased Platelet Aggregation [PE]
    • Platelet Aggregation Inhibitor [EPC]
    • Decreased Platelet Aggregation [PE]
    • Platelet Aggregation Inhibitor [EPC]

    NDC Crossover Matching brand name "Eptifibatide" or generic name "Eptifibatide"

    NDCBrand NameGeneric Name
    0338-9558EptifibatideEptifibatide
    0338-9559EptifibatideEptifibatide
    0703-1165EptifibatideEptifibatide
    14335-070Eptifibatideeptifibatide
    14335-071Eptifibatideeptifibatide
    16729-259EPTIFIBATIDEEptifibatide
    16729-260EPTIFIBATIDEEptifibatide
    17478-902EptifibatideEptifibatide
    17478-903EptifibatideEptifibatide
    25021-408eptifibatideeptifibatide
    25021-409eptifibatideeptifibatide
    52958-040EptifibatideEptifibatide
    52958-402EptifibatideEptifibatide
    70121-1002EptifibatideEptifibatide
    70121-1003EptifibatideEptifibatide
    55150-219EptifibatideEptifibatide
    55150-220EptifibatideEptifibatide
    55150-218EptifibatideEptifibatide
    59651-014EptifibatideEptifibatide
    59651-013EptifibatideEptifibatide
    59651-012EptifibatideEptifibatide
    67457-629EptifibatideEptifibatide
    67457-630EptifibatideEptifibatide
    67457-631EptifibatideEptifibatide
    70436-027EptifibatideEptifibatide
    70436-026EptifibatideEptifibatide
    62147-0601EptifibatideEptifibatide
    62147-0602EptifibatideEptifibatide
    62147-0600EptifibatideEptifibatide
    63739-970EptifibatideEptifibatide
    63739-923EptifibatideEptifibatide
    63739-911EptifibatideEptifibatide
    70436-163EptifibatideEptifibatide
    72078-025EptifibatideEptifibatide
    72078-027EptifibatideEptifibatide
    72078-026EptifibatideEptifibatide
    70436-162EptifibatideEptifibatide
    0085-1136IntegrilinEptifibatide
    0085-1177IntegrilinEptifibatide

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.