NDC 69097-262

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 Cipla Usa Inc.. The primary component is Topotecan Hydrochloride.

Product ID69097-262_4e757b90-6761-4586-914f-6bc194402399
NDC69097-262
Product TypeHuman Prescription Drug
Proprietary NameTOPOTECAN HYDROCHLORIDE
Generic NameTopotecan Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA091199
Labeler NameCipla USA Inc.
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 69097-262-67

1 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-67) > 4 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-262-67 [69097026267]

TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091199
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-01

NDC 69097-262-68 [69097026268]

TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091199
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-01

Drug Details

Active Ingredients

IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

OpenFDA Data

SPL SET ID:dd90b707-73c7-4d71-8d23-1ebbae251da1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1799416
  • 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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