NDC 0143-9513

Palonosetron Hydrochloride

Palonosetron Hydrochloride

Palonosetron Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Palonosetron Hydrochloride.

• Product ID: 0143-9513_7dc05b1a-344a-410b-a7b3-171727713cf1
• NDC: 0143-9513
• Product Type: Human Prescription Drug
• Proprietary Name: Palonosetron Hydrochloride
• Generic Name: Palonosetron Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA207963
• Labeler Name: West-Ward Pharmaceuticals Corp
• Substance Name: PALONOSETRON HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/2mL
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0143-9513-01

2 mL in 1 VIAL (0143-9513-01)

• Marketing Start Date: 2017-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9513-01 [00143951301]

Palonosetron Hydrochloride INJECTION

• Marketing Category: NDA
• Application Number: NDA207963
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-09-01

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.25 mg/2mL

OpenFDA Data

• SPL SET ID: bb20ba9b-aa8c-4b24-8124-aff0cb6c956b
• Manufacturer:
  • West-Ward Pharmaceuticals Corp
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 1947301

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-9513	Palonosetron Hydrochloride	Palonosetron Hydrochloride
0409-2504	Palonosetron Hydrochloride	PALONOSETRON HYDROCHLORIDE
0703-4094	Palonosetron Hydrochloride	Palonosetron Hydrochloride
0781-3312	Palonosetron Hydrochloride	Palonosetron Hydrochloride
0781-3415	Palonosetron Hydrochloride	Palonosetron Hydrochloride
16729-365	palonosetron hydrochloride	palonosetron hydrochloride
23155-356	Palonosetron Hydrochloride	Palonosetron Hydrochloride
25021-783	palonosetron hydrochloride	palonosetron hydrochloride
25021-788	palonosetron hydrochloride	palonosetron hydrochloride
36000-326	Palonosetron Hydrochloride	palonosetron hydrochloride
50742-485	Palonosetron Hydrochloride	Palonosetron Hydrochloride
55150-186	Palonosetron Hydrochloride	Palonosetron Hydrochloride
67457-317	Palonosetron Hydrochloride	Palonosetron Hydrochloride
69097-927	palonosetron hydrochloride	palonosetron hydrochloride
69097-439	Palonosetron hydrochloride	Palonosetron hydrochloride
69543-371	Palonosetron hydrochloride	Palonosetron hydrochloride
62856-797	Aloxi	palonosetron hydrochloride
62856-798	Aloxi	palonosetron hydrochloride
60505-6193	Palonosetron	Palonosetron Hydrochloride
67184-0514	Palonosetron	Palonosetron Hydrochloride
67184-0515	Palonosetron	Palonosetron Hydrochloride