NDC 25021-236

topotecan

Topotecan

topotecan is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is Topotecan Hydrochloride.

Product ID25021-236_5c7ca55c-2902-41c6-930c-0335f809d0ee
NDC25021-236
Product TypeHuman Prescription Drug
Proprietary Nametopotecan
Generic NameTopotecan
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-15
Marketing CategoryNDA / NDA
Application NumberNDA022453
Labeler NameSagent Pharmaceuticals
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 25021-236-04

1 VIAL in 1 CARTON (25021-236-04) > 4 mL in 1 VIAL
Marketing Start Date2014-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-236-04 [25021023604]

topotecan INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA022453
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-15
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:e5e6600e-6f92-4dc9-a8f3-cf647471d3cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799424
  • Pharmacological Class

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

    NDC Crossover Matching brand name "topotecan" or generic name "Topotecan"

    NDCBrand NameGeneric Name
    0409-0302TopotecanTOPOTECAN
    0703-4714TopotecanTopotecan
    16729-243TopotecanTopotecan
    25021-236topotecantopotecan
    50742-404TopotecanTopotecan
    66758-051TopotecanTopotecan
    67457-662TOPOTECANTOPOTECAN
    71288-127TopotecanTopotecan Hydrochloride
    0078-0672HYCAMTINtopotecan
    0078-0673HYCAMTINtopotecan

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