NDC 63323-673

Palonosetron

Palonosetron

Palonosetron 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 Palonosetron Hydrochloride.

• Product ID: 63323-673_64f40904-eef3-4353-b450-b945e86a7654
• NDC: 63323-673
• Product Type: Human Prescription Drug
• Proprietary Name: Palonosetron
• Generic Name: Palonosetron
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-09-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206801
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: PALONOSETRON HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/5mL
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63323-673-05

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-673-89 [63323067389]

Palonosetron INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206801
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-19

NDC 63323-673-21 [63323067321]

Palonosetron INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206801
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-19

NDC 63323-673-05 [63323067305]

Palonosetron INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206802
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-19

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.25 mg/5mL

OpenFDA Data

• SPL SET ID: b93fae8e-2b76-421e-95bc-ba08c211a7ea
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 2056929
• UPC Code:
  • 0363323673215

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