NDC 0143-9376

Etoposide

Etoposide

Etoposide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Etoposide.

Product ID0143-9376_59f81d09-9385-478e-a1d7-19588a08a239
NDC0143-9376
Product TypeHuman Prescription Drug
Proprietary NameEtoposide
Generic NameEtoposide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA074290
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameETOPOSIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9376-01

1 VIAL in 1 BOX, UNIT-DOSE (0143-9376-01) > 5 mL in 1 VIAL
Marketing Start Date2019-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9376-01 [00143937601]

Etoposide INJECTION
Marketing CategoryANDA
Application NumberANDA074290
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-01

Drug Details

Active Ingredients

IngredientStrength
ETOPOSIDE20 mg/mL

OpenFDA Data

SPL SET ID:e0cd61b9-2375-4e3d-a610-d87dad962468
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310248
  • Pharmacological Class

    • Topoisomerase Inhibitor [EPC]
    • Topoisomerase Inhibitors [MoA]
    • Topoisomerase Inhibitor [EPC]
    • Topoisomerase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0143-9376EtoposideEtoposide
    0143-9510EtoposideEtoposide
    0143-9511EtoposideEtoposide
    0143-9512EtoposideEtoposide
    0378-3266Etoposideetoposide
    16729-114EtoposideEtoposide
    16729-262EtoposideEtoposide
    63323-104EtoposideETOPOSIDE
    68001-265EtoposideEtoposide
    0703-5653ToposarEtoposide
    0703-5656ToposarEtoposide
    0703-5657ToposarEtoposide

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