NDC 69097-369

Docetaxel Anhydrous

Docetaxel Anhydrous

Docetaxel Anhydrous is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Docetaxel Anhydrous.

Product ID69097-369_45fc4959-659e-4b0a-8c0f-7aa2055e7708
NDC69097-369
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel Anhydrous
Generic NameDocetaxel Anhydrous
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-08-24
Marketing CategoryANDA / ANDA
Application NumberANDA209634
Labeler NameCipla USA Inc.
Substance NameDOCETAXEL ANHYDROUS
Active Ingredient Strength20 mg/2mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69097-369-32

1 VIAL, SINGLE-USE in 1 CARTON (69097-369-32) > 2 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2018-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-369-32 [69097036932]

Docetaxel Anhydrous INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209634
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-24

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL ANHYDROUS20 mg/2mL

OpenFDA Data

SPL SET ID:230104b9-368f-453f-b1eb-c69cfbcad7ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860619
  • 1093280

    • Pharmacological Class

    • Microtubule Inhibition [PE]
    • Microtubule Inhibitor [EPC]

    NDC Crossover Matching brand name "Docetaxel Anhydrous" or generic name "Docetaxel Anhydrous"

    NDCBrand NameGeneric Name
    69097-369Docetaxel AnhydrousDocetaxel Anhydrous
    69097-371Docetaxel AnhydrousDocetaxel Anhydrous
    69097-372Docetaxel AnhydrousDocetaxel Anhydrous
    71288-144Docetaxel anhydrousDocetaxel anhydrous
    71288-143Docetaxel anhydrousDocetaxel anhydrous
    0409-0016DocetaxelDOCETAXEL ANHYDROUS
    0409-0201DocetaxelDOCETAXEL ANHYDROUS
    0409-1732DocetaxelDOCETAXEL ANHYDROUS
    0409-2026DocetaxelDOCETAXEL ANHYDROUS
    0409-7870DocetaxelDOCETAXEL ANHYDROUS
    25021-245DocetaxelDocetaxel Anhydrous
    50742-428DOCETAXELDOCETAXEL ANHYDROUS
    50742-431DOCETAXELDOCETAXEL ANHYDROUS
    50742-463DOCETAXELDOCETAXEL ANHYDROUS
    67457-531DocetaxelDOCETAXEL ANHYDROUS
    67457-532DocetaxelDOCETAXEL ANHYDROUS
    67457-533DocetaxelDOCETAXEL ANHYDROUS
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.