0310-0625 : Koselugo 25 mg Oral Capsule


NDC0310-0625
Labeler: Astrazeneca Pharmaceuticals Lp
Product Type: Human Prescription Drug
Drug Name:  Koselugo
Dosage Form: Oral Capsule
Application #: NDA213756
Rev. Date: 


Appearance:


Markings: SEL;25
Shapes:  Capsule
Colors:  Blue
Size (mm): 14
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:

  • 0310-0625-28: 28 CAPSULE IN 1 BOTTLE (0310‑0625‑28)
  • 0310-0625-60: 60 CAPSULE IN 1 BOTTLE (0310‑0625‑60)

Active Ingredients:

  • Selumetinib

Dosage Strength:

  • 25 mg

Inactive Ingredients:

  • Tocophersolan
  • Hypromellose, Unspecified
  • Carrageenan
  • Potassium Chloride
  • Fd&c Blue No. 2
  • Ferric Oxide Yellow
  • Titanium Dioxide
  • Ferric Oxide Red
  • Carnauba Wax
  • Shellac
  • 1-butanol, 4-(ethenyloxy)-
  • Alcohol
  • Water
  • Glyceryl Oleate /

Pharmaceutical Classes:

  • Kinase Inhibitor [EPC]
  • Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA]
  • Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0310-0610 Koselugo 10 mg Oral Capsule by Astrazeneca Pharmaceuticals Lp

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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.