62856-796 : Akynzeo Oral Capsule

Labeler: Eisai Inc.
Product Type: Human Prescription Drug
Drug Name:  Akynzeo
Dosage Form: Oral Capsule
Application #: NDA205718
Rev. Date: 


Markings: HE1
Shapes:  Capsule
Colors:  White / Brown
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 62856-796-01: 1 BLISTER PACK IN 1 CARTON (62856‑796‑01) > 1 CAPSULE IN 1 BLISTER PACK
  • 62856-796-04: 2 BLISTER PACK IN 1 CARTON (62856‑796‑04) > 2 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Netupitant
  • Palonosetron

Dosage Strength:

  • 300 mg
  • .5 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Sucrose Laurate
  • Povidone K30
  • Croscarmellose Sodium
  • Water
  • Silicon Dioxide
  • Sodium Stearyl Fumarate
  • Magnesium Stearate
  • Caprylic/Capric Mono/Diglycerides
  • Glycerin
  • Polyglyceryl-3 Dioleate
  • Butylated Hydroxyanisole
  • Gelatin
  • Sorbitol
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Ferric Oxide Red

Pharmaceutical 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]

Related Products:

Based on records with the same trade name.
  • 69639-101 Akynzeo Oral Capsule by Helsinn Therapeutics (U.s.), Inc.
  • 69639-102 Akynzeo Intravenous Injection by Helsinn Therapeutics (U.s.), Inc.


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