NDC 66758-050

Docetaxel

Docetaxel

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

Product ID66758-050_1ec94e98-069d-42aa-8a94-acfb5c54b6a2
NDC66758-050
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-06-29
Marketing CategoryNDA / NDA
Application NumberNDA201525
Labeler NameSandoz Inc.
Substance NameDOCETAXEL
Active Ingredient Strength10 mg/mL
Pharm ClassesMicrotubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 66758-050-01

1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01) > 2 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2011-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-050-02 [66758005002]

Docetaxel INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA201525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-06-29

NDC 66758-050-03 [66758005003]

Docetaxel INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA201525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-06-29

NDC 66758-050-01 [66758005001]

Docetaxel INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA201525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-06-29

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL10 mg/mL

OpenFDA Data

SPL SET ID:e03d1378-6889-43d5-a34c-f96132cffa88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1093280
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-9204DocetaxelDocetaxel
    0143-9205DocetaxelDocetaxel
    0409-0016DocetaxelDOCETAXEL ANHYDROUS
    0409-0201DocetaxelDOCETAXEL ANHYDROUS
    0409-0365DocetaxelDOCETAXEL
    0409-0366DocetaxelDOCETAXEL
    0409-0367DocetaxelDOCETAXEL
    0409-0368DocetaxelDOCETAXEL
    0409-1732DocetaxelDOCETAXEL ANHYDROUS
    0409-2026DocetaxelDOCETAXEL ANHYDROUS
    0409-4235DocetaxelDOCETAXEL
    70121-1222DocetaxelDocetaxel
    70121-1223DocetaxelDocetaxel
    70121-1221DocetaxelDocetaxel
    0955-1022DocetaxelDocetaxel
    0955-1020DocetaxelDocetaxel
    0955-1021DocetaxelDocetaxel
    16729-267DocetaxelDocetaxel
    16729-231DocetaxelDocetaxel
    25021-245DocetaxelDocetaxel
    39822-2200DocetaxelDocetaxel
    39822-2120DocetaxelDocetaxel
    39822-2180DocetaxelDocetaxel
    43066-001DocetaxelDocetaxel
    43066-006DocetaxelDocetaxel
    43066-010DocetaxelDocetaxel
    43598-610DocetaxelDocetaxel
    43598-258DocetaxelDocetaxel
    43598-259DocetaxelDocetaxel
    43598-611DocetaxelDocetaxel
    45963-790DocetaxelDocetaxel
    45963-734DocetaxelDocetaxel
    45963-765DocetaxelDocetaxel
    50742-428DOCETAXELDOCETAXEL
    50742-463DOCETAXELDOCETAXEL
    50742-431DOCETAXELDOCETAXEL
    57884-3043DocetaxelDocetaxel
    57884-3021DocetaxelDocetaxel
    57884-3042DocetaxelDocetaxel
    57884-3041DocetaxelDocetaxel
    63739-932DocetaxelDocetaxel
    63739-971DocetaxelDocetaxel
    66758-950DocetaxelDocetaxel
    66758-050DocetaxelDocetaxel
    67457-531DocetaxelDocetaxel
    67457-533DocetaxelDocetaxel
    67457-532DocetaxelDocetaxel
    67457-781DocetaxelDocetaxel
    0075-8003TAXOTEREDocetaxel
    0075-8004TAXOTEREDocetaxel

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