NDC 55390-370

Topotecan Hydrochloride

Topotecan Hydrochloride

Topotecan Hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bedford Laboratories. The primary component is Topotecan Hydrochloride.

Product ID55390-370_654d0d44-73a6-baa4-78ec-8fa492237dab
NDC55390-370
Product TypeHuman Prescription Drug
Proprietary NameTopotecan Hydrochloride
Generic NameTopotecan Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-04-18
Marketing CategoryANDA / ANDA
Application NumberANDA201191
Labeler NameBedford Laboratories
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/4mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55390-370-10

1 VIAL in 1 CARTON (55390-370-10) > 4 mL in 1 VIAL
Marketing Start Date2020-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

OpenFDA Data

SPL SET ID:a439bf07-53db-0352-846a-99d9da772f9b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799416

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    16729-151topotecan hydrochloridetopotecan hydrochloride
    45963-615Topotecan hydrochlorideTopotecan hydrochloride
    55390-370Topotecan HydrochlorideTopotecan Hydrochloride
    63323-762Topotecan HydrochlorideTOPOTECAN HYDROCHLORIDE
    69097-262TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDE
    0078-0674HYCAMTINtopotecan hydrochloride
    71288-127TopotecanTopotecan Hydrochloride
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