NDC 50742-404

Topotecan

Topotecan

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

Product ID50742-404_067b1d4b-d34e-437f-a777-f4c5f3310032
NDC50742-404
Product TypeHuman Prescription Drug
Proprietary NameTopotecan
Generic NameTopotecan
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-12-07
Marketing CategoryANDA / ANDA
Application NumberANDA206962
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameTOPOTECAN HYDROCHLORIDE
Active Ingredient Strength4 mg/4mL
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50742-404-01

4 mL in 1 VIAL (50742-404-01)
Marketing Start Date2016-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-404-01 [50742040401]

Topotecan INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-07

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

OpenFDA Data

SPL SET ID:3172d23a-e915-4a16-a068-67dfd09c473d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799416
  • 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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