NDC 45963-613

Paclitaxel

Paclitaxel

Paclitaxel is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Paclitaxel.

Product ID45963-613_2e201132-4f34-44e5-98a0-48fa8d952aa1
NDC45963-613
Product TypeHuman Prescription Drug
Proprietary NamePaclitaxel
Generic NamePaclitaxel
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-07-19
Marketing CategoryANDA / ANDA
Application NumberANDA090130
Labeler NameActavis Pharma, Inc.
Substance NamePACLITAXEL
Active Ingredient Strength6 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 45963-613-53

1 VIAL, MULTI-DOSE in 1 CARTON (45963-613-53) > 16.7 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2018-07-19
Marketing End Date2022-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-613-89 [45963061389]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-13
Marketing End Date2021-08-31

NDC 45963-613-86 [45963061386]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-13

NDC 45963-613-83 [45963061383]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-13
Marketing End Date2021-04-30

NDC 45963-613-59 [45963061359]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-19
Marketing End Date2022-06-30

NDC 45963-613-56 [45963061356]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-19

NDC 45963-613-53 [45963061353]

Paclitaxel INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-19
Marketing End Date2022-07-31

Drug Details

Active Ingredients

IngredientStrength
PACLITAXEL6 mg/mL

OpenFDA Data

SPL SET ID:6cefbdb9-1141-4a53-9d05-f6fcc2746834
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312199
  • UPC Code
  • 0345963613561
  • 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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