NDC 25021-788

palonosetron hydrochloride

Palonosetron Hydrochloride

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

• Product ID: 25021-788_e99396b8-332b-413c-bbe7-a86c373147fe
• NDC: 25021-788
• Product Type: Human Prescription Drug
• Proprietary Name: palonosetron hydrochloride
• Generic Name: Palonosetron Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-12-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205870
• Labeler Name: Sagent Pharmaceuticals
• 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: 2020-12-31

Packaging

NDC 25021-788-74

5 SYRINGE in 1 CARTON (25021-788-74) > 5 mL in 1 SYRINGE

• Marketing Start Date: 2018-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25021-788-74 [25021078874]

palonosetron hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205870
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-12-15

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.05 mg/mL

OpenFDA Data

• SPL SET ID: 2183785c-d3f5-4b4a-b019-a88b3c792ae2
• Manufacturer:
  • Sagent Pharmaceuticals
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 2056929

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