NDC 45963-615

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 Actavis Pharma, Inc.. The primary component is Topotecan Hydrochloride.

Product ID45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d
NDC45963-615
Product TypeHuman Prescription Drug
Proprietary NameTopotecan hydrochloride
Generic NameTopotecan Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA090620
Labeler NameActavis Pharma, Inc.
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/4mL
Pharm ClassesTopoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 45963-615-56

1 VIAL in 1 CARTON (45963-615-56) > 4 mL in 1 VIAL
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-615-56 [45963061556]

Topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

OpenFDA Data

SPL SET ID:996430c0-ee26-4ed9-82b8-a8b645becba6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799416
  • UPC Code
  • 0345963615565
  • 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

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