NDC 68083-178

PACLITAXEL PACLITAXEL

Paclitaxel

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

Product ID68083-178_aeff20f1-c4e7-46c6-a6cb-f0aab334571b
NDC68083-178
Product TypeHuman Prescription Drug
Proprietary NamePACLITAXEL PACLITAXEL
Generic NamePaclitaxel
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA207326
Labeler NameGland Pharma Limited
Substance NamePACLITAXEL
Active Ingredient Strength6 mg/mL
Pharm ClassesMicrotubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-178-01

1 VIAL, MULTI-DOSE in 1 CARTON (68083-178-01) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2016-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-178-01 [68083017801]

PACLITAXEL PACLITAXEL INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207326
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

Drug Details

Active Ingredients

IngredientStrength
PACLITAXEL6 mg/mL

OpenFDA Data

SPL SET ID:fec9ddee-53a9-4a61-ad0a-be6b604de084
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312199
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68083-179PACLITAXEL PACLITAXELPACLITAXEL PACLITAXEL
    68083-180PACLITAXEL PACLITAXELPACLITAXEL PACLITAXEL
    68083-178PACLITAXEL PACLITAXELPACLITAXEL PACLITAXEL
    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
    24979-710Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)Paclitaxel

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