NDC 0075-8003

TAXOTERE

Docetaxel

TAXOTERE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Docetaxel.

Product ID0075-8003_519e570f-c38f-45eb-bdd4-e373691f3d79
NDC0075-8003
Product TypeHuman Prescription Drug
Proprietary NameTAXOTERE
Generic NameDocetaxel
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-08-02
Marketing End Date2020-03-31
Marketing CategoryNDA / NDA
Application NumberNDA020449
Labeler NameSanofi-Aventis U.S. LLC
Substance NameDOCETAXEL
Active Ingredient Strength20 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN

Packaging

NDC 0075-8003-01

1 VIAL, GLASS in 1 CARTON (0075-8003-01) > 1 mL in 1 VIAL, GLASS
Marketing Start Date2010-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0075-8003-01 [00075800301]

TAXOTERE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA020449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-02
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL20 mg/mL

OpenFDA Data

SPL SET ID:45e6dce4-92e2-4ad1-bf11-bbcefb753636
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860485
  • 1860486
  • 1860480
  • 1860482
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0075-8003TAXOTEREDocetaxel
    0075-8004TAXOTEREDocetaxel
    0143-9204DocetaxelDocetaxel
    0143-9205DocetaxelDocetaxel
    0409-0365DocetaxelDOCETAXEL
    0409-0366DocetaxelDOCETAXEL
    0409-0367DocetaxelDOCETAXEL
    0409-0368DocetaxelDOCETAXEL
    0409-4235DocetaxelDOCETAXEL
    0409-5068DocetaxelDOCETAXEL
    0955-1020DocetaxelDocetaxel
    0955-1021DocetaxelDocetaxel

    Trademark Results [TAXOTERE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TAXOTERE
    TAXOTERE
    74693833 1999459 Live/Registered
    AVENTIS PHARMA S.A.
    1995-06-26
    TAXOTERE
    TAXOTERE
    74046910 1661411 Live/Registered
    RHONE-POULENC SANTE
    1990-04-09

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