NDC 68001-355

Palonosetron

Palonosetron

Palonosetron is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Palonosetron Hydrochloride.

• Product ID: 68001-355_4c971ec3-8bb4-42c3-8cb9-36270e2f95be
• NDC: 68001-355
• Product Type: Human Prescription Drug
• Proprietary Name: Palonosetron
• Generic Name: Palonosetron
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201533
• Labeler Name: BluePoint Laboratories
• Substance Name: PALONOSETRON HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68001-355-25

1 VIAL, SINGLE-USE in 1 CARTON (68001-355-25) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68001-355-25 [68001035525]

Palonosetron INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201533
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-05-30

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.05 mg/mL

OpenFDA Data

• SPL SET ID: ee6f6f94-1ca7-481e-9909-b19ae64e80c2
• Manufacturer:
  • BluePoint Laboratories
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 1728055
• UPC Code:
  • 0368001355254

Pharmacological Class

• Serotonin 3 Receptor Antagonists [MoA]
• Serotonin-3 Receptor Antagonist [EPC]

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

NDC	Brand Name	Generic Name
16714-834	Palonosetron	Palonosetron
55111-694	Palonosetron	Palonosetron
60505-6193	Palonosetron	Palonosetron Hydrochloride
63323-673	Palonosetron	Palonosetron
63323-942	Palonosetron	Palonosetron
67184-0514	Palonosetron	Palonosetron Hydrochloride
67184-0515	Palonosetron	Palonosetron Hydrochloride
68001-355	Palonosetron	Palonosetron
68001-482	Palonosetron	Palonosetron Hydrochloride