NDC 63323-762

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 Fresenius Kabi Usa, Llc. The primary component is Topotecan Hydrochloride.

Product ID63323-762_11dbb5b9-c1ad-410b-aea7-cd05239a3645
NDC63323-762
Product TypeHuman Prescription Drug
Proprietary NameTopotecan Hydrochloride
Generic NameTopotecan Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA091089
Labeler NameFresenius Kabi USA, LLC
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/4mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63323-762-94

1 VIAL in 1 BOX (63323-762-94) > 4 mL in 1 VIAL
Marketing Start Date2010-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-762-17 [63323076217]

Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091089
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-30
Marketing End Date2018-12-26

NDC 63323-762-94 [63323076294]

Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091089
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-30

NDC 63323-762-57 [63323076257]

Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091376
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-31
Marketing End Date2016-03-18

NDC 63323-762-55 [63323076255]

Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091376
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-31
Marketing End Date2016-03-18

NDC 63323-762-10 [63323076210]

Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091089
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-30

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

OpenFDA Data

SPL SET ID:b6019088-cd94-43b4-b5ce-ba20b6b8021e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799416
  • UPC Code
  • 0363323762100
  • Pharmacological Class

    • 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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