NDC 68817-134

ABRAXANE

Paclitaxel

ABRAXANE is a Intravenous Injection, Powder, Lyophilized, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Abraxis Bioscience, Llc. The primary component is Paclitaxel.

• Product ID: 68817-134_0727ce20-fbf4-4233-b056-d6a8ab033519
• NDC: 68817-134
• Product Type: Human Prescription Drug
• Proprietary Name: ABRAXANE
• Generic Name: Paclitaxel
• Dosage Form: Injection, Powder, Lyophilized, For Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2005-02-10
• Marketing Category: NDA / NDA
• Application Number: NDA021660
• Labeler Name: Abraxis BioScience, LLC
• Substance Name: PACLITAXEL
• Active Ingredient Strength: 100 mg/20mL
• Pharm Classes: Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68817-134-50

1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) > 20 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2005-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68817-134-50 [68817013450]

ABRAXANE INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021660
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-02-10

Drug Details

Active Ingredients

Ingredient	Strength
PACLITAXEL	100 mg/20mL

OpenFDA Data

• SPL SET ID: 24d10449-2936-4cd3-b7db-a7683db721e4
• Manufacturer:
  • Abraxis BioScience, LLC
• UNII:
  • P88XT4IS4D
• RxNorm Concept Unique ID - RxCUI:
  • 583214
  • 583218
• UPC Code:
  • 0368817134500

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
68817-134	ABRAXANE	ABRAXANE
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