NDC 69639-101

AKYNZEO

Netupitant And Palonosetron

AKYNZEO 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 Netupitant; Palonosetron.

• Product ID: 69639-101_13e49207-5307-4add-ab8d-a5bdc8138704
• NDC: 69639-101
• Product Type: Human Prescription Drug
• Proprietary Name: AKYNZEO
• Generic Name: Netupitant And Palonosetron
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-13
• Marketing Category: NDA / NDA
• Application Number: NDA205718
• Labeler Name: Helsinn Therapeutics (U.S.), Inc.
• Substance Name: NETUPITANT; PALONOSETRON
• Active Ingredient Strength: 300 mg/1; mg/1
• Pharm Classes: Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69639-101-01

1 BLISTER PACK in 1 CARTON (69639-101-01) > 1 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2014-10-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69639-101-01 [69639010101]

AKYNZEO CAPSULE

• Marketing Category: NDA
• Application Number: NDA205718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-13

NDC 69639-101-04 [69639010104]

AKYNZEO CAPSULE

• Marketing Category: NDA
• Application Number: NDA205718
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-13

Drug Details

Active Ingredients

Ingredient	Strength
NETUPITANT	300 mg/1

OpenFDA Data

• SPL SET ID: 8e47618e-af46-4d82-94e8-1507c042252d
• Manufacturer:
  • Helsinn Therapeutics (U.S.), Inc.
• UNII:
  • 23310D4I19
  • 7732P08TIR
  • T672P80L2S
  • 5D06587D6R
• RxNorm Concept Unique ID - RxCUI:
  • 1552349
  • 2044429
  • 1552343
  • 2044431
• UPC Code:
  • 0369639101046

Pharmacological Class

• Neurokinin 1 Antagonists [MoA]
• Substance P/Neurokinin-1 Receptor Antagonist [EPC]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Serotonin 3 Receptor Antagonists [MoA]
• Serotonin-3 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "AKYNZEO" or generic name "Netupitant And Palonosetron"

NDC	Brand Name	Generic Name
69639-101	AKYNZEO	Netupitant and Palonosetron
69639-102	AKYNZEO	Fosnetupitant and Palonosetron
69639-105	AKYNZEO	Fosnetupitant and Palonosetron