NDC 67457-532

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 ID67457-532_10fa26f0-4cd0-4285-accc-8f74e015b7df
NDC67457-532
Product TypeHuman Prescription Drug
Proprietary NameDocetaxel
Generic NameDocetaxel Anhydrous
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA210848
Labeler NameMylan Institutional LLC
Substance NameDOCETAXEL ANHYDROUS
Active Ingredient Strength10 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-532-08

1 VIAL, MULTI-DOSE in 1 CARTON (67457-532-08) > 8 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2018-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-532-08 [67457053208]

Docetaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210848
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:79c77be0-7e8c-400d-beb9-89d78b01be7f
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 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

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