69639-101 : Akynzeo Oral Capsule


NDC: 69639-101
Labeler: Helsinn Therapeutics (U.s.), Inc.
Product Type: Human Prescription Drug
Drug Name:  Akynzeo
Dosage Form: Oral Capsule
Application #: NDA205718
Rev. Date: 


Appearance:


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:

  • 69639-101-01: 1 BLISTER PACK IN 1 CARTON (69639‑101‑01) > 1 CAPSULE IN 1 BLISTER PACK
  • 69639-101-04: 2 BLISTER PACK IN 1 CARTON (69639‑101‑04) > 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:

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

Related Products:

Based on records with the same trade name.
  • 69639-102 Akynzeo Intravenous Injection by Helsinn Therapeutics (U.s.), Inc.
  • 69639-105 Akynzeo Intravenous Injection by Helsinn Therapeutics (U.s.), Inc.
  • 69639-106 Akynzeo Intravenous Injection by Helsinn Therapeutics (U.s.), Inc.
  • 62856-796 Akynzeo Oral Capsule by Eisai Inc.

NDC QR Code

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NDC 69639-101 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.