NDC 63323-763

Paclitaxel

Paclitaxel

Paclitaxel is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Paclitaxel.

• Product ID: 63323-763_423bcbc2-3aea-4c53-b93a-d5af7224886e
• NDC: 63323-763
• Product Type: Human Prescription Drug
• Proprietary Name: Paclitaxel
• Generic Name: Paclitaxel
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-08-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090130
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: PACLITAXEL
• Active Ingredient Strength: 6 mg/mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-763-05

1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-05) > 5 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2009-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-763-16 [63323076316]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077574
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-03-20

NDC 63323-763-06 [63323076306]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090130
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-15
• Marketing End Date: 2017-01-31

NDC 63323-763-50 [63323076350]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077574
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-03-20

NDC 63323-763-52 [63323076352]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090130
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-15
• Marketing End Date: 2017-02-28

NDC 63323-763-05 [63323076305]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA077574
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-03-20

NDC 63323-763-17 [63323076317]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090130
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-15
• Marketing End Date: 2016-12-31

Drug Details

Active Ingredients

Ingredient	Strength
PACLITAXEL	6 mg/mL

OpenFDA Data

• SPL SET ID: f10f730f-6479-4f6a-8edc-fa4bd2140c1b
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • P88XT4IS4D
• RxNorm Concept Unique ID - RxCUI:
  • 312199
• UPC Code:
  • 0363323763060

Pharmacological Class

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

Medicade Reported Pricing

63323076350 PACLITAXEL 300 MG/50 ML VIAL

Pricing Unit: ML | Drug Type:

63323076316 PACLITAXEL 100 MG/16.7 ML VIAL

Pricing Unit: ML | Drug Type:

63323076305 PACLITAXEL 30 MG/5 ML VIAL

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
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
70860-200	Paclitaxel	Paclitaxel
47781-595	Paclitaxel	Paclitaxel
47781-594	Paclitaxel	Paclitaxel
51991-938	Paclitaxel	Paclitaxel
51991-937	Paclitaxel	Paclitaxel
51991-936	Paclitaxel	Paclitaxel
61703-342	Paclitaxel	Paclitaxel
63323-763	Paclitaxel	Paclitaxel
67457-449	Paclitaxel	Paclitaxel
67457-434	Paclitaxel	Paclitaxel
67457-471	Paclitaxel	Paclitaxel
70860-215	Paclitaxel	Paclitaxel
24979-710	Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)	Paclitaxel