NDC 69639-104

ALOXI

Palonosetron Hydrochloride

ALOXI is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Palonosetron Hydrochloride.

• Product ID: 69639-104_327cc7a4-5261-49cc-9e30-e7fffc9662ee
• NDC: 69639-104
• Product Type: Human Prescription Drug
• Proprietary Name: ALOXI
• Generic Name: Palonosetron Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-05-28
• Marketing Category: NDA / NDA
• Application Number: NDA022233
• Labeler Name: Helsinn Therapeutics (U.S.), Inc.
• Substance Name: PALONOSETRON HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/.5mg
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69639-104-05

5 CAPSULE in 1 CARTON (69639-104-05) > .5 mg in 1 CAPSULE

• Marketing Start Date: 2014-05-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69639-104-05 [69639010405]

ALOXI CAPSULE

• Marketing Category: NDA
• Application Number: NDA022233
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-05-28

Drug Details

Active Ingredients

Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.5 mg/.5mg

OpenFDA Data

• SPL SET ID: ab89d423-4275-4651-9ae7-9002f17ab0a1
• Manufacturer:
  • Helsinn Therapeutics (U.S.), Inc.
• UNII:
  • 23310D4I19
• RxNorm Concept Unique ID - RxCUI:
  • 805448
  • 805451
• UPC Code:
  • 0369639104054

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
62856-797	Aloxi	palonosetron hydrochloride
62856-798	Aloxi	palonosetron hydrochloride
69639-103	Aloxi	Aloxi
69639-104	ALOXI	ALOXI
60505-6193	Palonosetron	Palonosetron Hydrochloride
67184-0514	Palonosetron	Palonosetron Hydrochloride
67184-0515	Palonosetron	Palonosetron Hydrochloride
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