NDC 67457-662

TOPOTECAN

Topotecan

TOPOTECAN is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Topotecan Hydrochloride.

Product ID67457-662_0cd4acf2-b424-4a8a-8e82-e842a46b387a
NDC67457-662
Product TypeHuman Prescription Drug
Proprietary NameTOPOTECAN
Generic NameTopotecan
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-04-09
Marketing CategoryANDA / ANDA
Application NumberANDA206074
Labeler NameMylan Institutional LLC
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-662-05

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-662-05) > 4 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-662-05 [67457066205]

TOPOTECAN INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA206074
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-04-09

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:af5891cf-e778-4dc3-9bfd-a29175755584
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799424
  • UPC Code
  • 0367457662053
  • 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

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