NDC 0703-4764

Paclitaxel

Paclitaxel

Paclitaxel is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Paclitaxel.

Product ID0703-4764_0b02547e-0b69-4044-9495-f5b7f287e2c6
NDC0703-4764
Product TypeHuman Prescription Drug
Proprietary NamePaclitaxel
Generic NamePaclitaxel
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-03-03
Marketing CategoryANDA / ANDA
Application NumberANDA075184
Labeler NameTeva Parenteral Medicines, Inc.
Substance NamePACLITAXEL
Active Ingredient Strength6 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0703-4764-81

1 VIAL, MULTI-DOSE in 1 CARTON (0703-4764-81) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2016-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-4764-81 [00703476481]

Paclitaxel INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA075184
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-03

NDC 0703-4764-01 [00703476401]

Paclitaxel INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA075184
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-11-03
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
PACLITAXEL6 mg/mL

OpenFDA Data

SPL SET ID:88d7cdd2-e650-4a16-adec-873927e03e93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312199
  • 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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