NDC 16729-365

palonosetron hydrochloride

Palonosetron Hydrochloride

palonosetron hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Palonosetron Hydrochloride.

• Product ID: 16729-365_681ba424-52d7-f891-e053-2991aa0a8344
• NDC: 16729-365
• Product Type: Human Prescription Drug
• Proprietary Name: palonosetron hydrochloride
• Generic Name: Palonosetron Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-03-23
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021372
• Labeler Name: Accord Healthcare, Inc.
• 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: 2019-12-31

Packaging

NDC 16729-365-66

1 VIAL in 1 CARTON (16729-365-66) > 5 mL in 1 VIAL

• Marketing Start Date: 2018-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16729-365-66 [16729036566]

palonosetron hydrochloride INJECTION

• Marketing Category: NDA authorized generic
• Application Number: NDA021372
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-03-23

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.25 mg/5mL

OpenFDA Data

• SPL SET ID: a598e42a-2580-47b9-a9bf-13d6283fadb7
• Manufacturer:
  • Accord Healthcare, Inc.
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 1728055
• UPC Code:
  • 0316729365666

Pharmacological Class

• 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