NDC 50742-431

DOCETAXEL

Docetaxel Anhydrous

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

Product ID50742-431_022dc11f-b37d-4885-bf1a-99ba78f93114
NDC50742-431
Product TypeHuman Prescription Drug
Proprietary NameDOCETAXEL
Generic NameDocetaxel Anhydrous
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA207563
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameDOCETAXEL ANHYDROUS
Active Ingredient Strength10 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50742-431-08

1 VIAL, MULTI-DOSE in 1 CARTON (50742-431-08) > 8 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-431-08 [50742043108]

DOCETAXEL INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-07

Drug Details

Active Ingredients

IngredientStrength
DOCETAXEL ANHYDROUS10 mg/mL

OpenFDA Data

SPL SET ID:b17679e8-88c8-4b8d-bfae-246fab6eead9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860619
  • 1093280
  • UPC Code
  • 0350742463169
  • 0350742431083
  • 0350742428021
  • 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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