NDC 51991-938

Paclitaxel

Paclitaxel

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

• Product ID: 51991-938_1fe275b1-bcc3-4644-9314-23dfc3a2f67d
• NDC: 51991-938
• Product Type: Human Prescription Drug
• Proprietary Name: Paclitaxel
• Generic Name: Paclitaxel
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-30
• Marketing End Date: 2019-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207326
• Labeler Name: Breckenridge Pharmaceutical, Inc.
• Substance Name: PACLITAXEL
• Active Ingredient Strength: 300 mg/50mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 51991-938-98

1 VIAL, MULTI-DOSE in 1 CARTON (51991-938-98) > 50 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2017-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51991-938-98 [51991093898]

Paclitaxel INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA207326
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-22
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
PACLITAXEL	300 mg/50mL

OpenFDA Data

• SPL SET ID: d29a737a-7a6f-41bc-8f7e-fef3823cb1b0
• Manufacturer:
  • Breckenridge Pharmaceutical, Inc.
• UNII:
  • P88XT4IS4D
• RxNorm Concept Unique ID - RxCUI:
  • 312199

Pharmacological Class

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

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