NDC 67457-449

Paclitaxel

Paclitaxel

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

Product ID67457-449_146658ae-b0aa-4fca-b5d1-58d798d5f92b
NDC67457-449
Product TypeHuman Prescription Drug
Proprietary NamePaclitaxel
Generic NamePaclitaxel
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-08-07
Marketing CategoryANDA / ANDA
Application NumberANDA091540
Labeler NameMylan Institutional LLC
Substance NamePACLITAXEL
Active Ingredient Strength100 mg/16.7mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-449-17

1 VIAL in 1 CARTON (67457-449-17) > 16.7 mL in 1 VIAL
Marketing Start Date2014-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-449-17 [67457044917]

Paclitaxel INJECTION
Marketing CategoryANDA
Application NumberANDA091540
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-08-07
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
PACLITAXEL100 mg/16.7mL

OpenFDA Data

SPL SET ID:9ffd3e34-537f-4f65-b00e-57c25bab3b01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312199
  • UPC Code
  • 0367457449173
  • 0367457434513
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0703-3213PaclitaxelPaclitaxel
    0703-3216PaclitaxelPaclitaxel
    0703-3217PaclitaxelPaclitaxel
    0703-3218PaclitaxelPaclitaxel
    0703-4764PaclitaxelPaclitaxel
    0703-4766PaclitaxelPaclitaxel
    0703-4767PaclitaxelPaclitaxel
    0703-4768PaclitaxelPaclitaxel
    16714-137PaclitaxelPaclitaxel
    16729-098PaclitaxelPACLITAXEL
    44567-504PaclitaxelPaclitaxel
    44567-505PaclitaxelPaclitaxel
    44567-506PaclitaxelPaclitaxel
    45963-613PaclitaxelPaclitaxel
    47781-593Paclitaxelpaclitaxel
    70860-200PaclitaxelPaclitaxel
    47781-595PaclitaxelPaclitaxel
    47781-594PaclitaxelPaclitaxel
    51991-938PaclitaxelPaclitaxel
    51991-937PaclitaxelPaclitaxel
    51991-936PaclitaxelPaclitaxel
    61703-342PaclitaxelPaclitaxel
    63323-763PaclitaxelPaclitaxel
    67457-449PaclitaxelPaclitaxel
    67457-434PaclitaxelPaclitaxel
    67457-471PaclitaxelPaclitaxel
    70860-215PaclitaxelPaclitaxel
    24979-710Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)Paclitaxel

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