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 ID: 68083-178_aeff20f1-c4e7-46c6-a6cb-f0aab334571b
• NDC: 68083-178
• Product Type: Human Prescription Drug
• Proprietary Name: PACLITAXEL PACLITAXEL
• Generic Name: Paclitaxel
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207326
• Labeler Name: Gland Pharma Limited
• Substance Name: PACLITAXEL
• Active Ingredient Strength: 6 mg/mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68083-178-01

1 VIAL, MULTI-DOSE in 1 CARTON (68083-178-01) > 5 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2016-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-178-01 [68083017801]

PACLITAXEL PACLITAXEL INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA207326
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-30

Drug Details

Active Ingredients

Ingredient	Strength
PACLITAXEL	6 mg/mL

OpenFDA Data

• SPL SET ID: fec9ddee-53a9-4a61-ad0a-be6b604de084
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • P88XT4IS4D
• 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"

NDC	Brand Name	Generic Name
68083-179	PACLITAXEL PACLITAXEL	PACLITAXEL PACLITAXEL
68083-180	PACLITAXEL PACLITAXEL	PACLITAXEL PACLITAXEL
68083-178	PACLITAXEL PACLITAXEL	PACLITAXEL PACLITAXEL
0703-3213	Paclitaxel	Paclitaxel
0703-3216	Paclitaxel	Paclitaxel
0703-3217	Paclitaxel	Paclitaxel
0703-3218	Paclitaxel	Paclitaxel
0703-4764	Paclitaxel	Paclitaxel
0703-4766	Paclitaxel	Paclitaxel
0703-4767	Paclitaxel	Paclitaxel
0703-4768	Paclitaxel	Paclitaxel
16714-137	Paclitaxel	Paclitaxel
16729-098	Paclitaxel	PACLITAXEL
44567-504	Paclitaxel	Paclitaxel
44567-505	Paclitaxel	Paclitaxel
44567-506	Paclitaxel	Paclitaxel
45963-613	Paclitaxel	Paclitaxel
47781-593	Paclitaxel	paclitaxel
24979-710	Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)	Paclitaxel