NDC 67457-531

Docetaxel

Docetaxel Anhydrous

Docetaxel is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Docetaxel Anhydrous.

Product ID67457-531_32dd793f-b2ca-4d4b-acf9-a77241ec959f
NDC67457-531
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel Anhydrous
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA210072
Labeler NameMylan Institutional LLC
Substance NameDOCETAXEL ANHYDROUS
Active Ingredient Strength10 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-531-02

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-531-02) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-531-02 [67457053102]

Docetaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210072
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-28

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL ANHYDROUS10 mg/mL

OpenFDA Data

SPL SET ID:2e924f96-442f-4da8-8044-4862dbeeabda
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860619
  • UPC Code
  • 0367457531021
  • Pharmacological Class

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

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

    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.