51167-300 : Kalydeco 50 mg Oral Granule

Labeler: Vertex Pharmaceuticals Incorporated
Product Type: Human Prescription Drug
Drug Name:  Kalydeco
Dosage Form: Oral Granule
Application #: NDA207925
Rev. Date: 

NDC Package Codes:

  • 51167-300-01: 56 GRANULE IN 1 CARTON (51167‑300‑01)

Active Ingredients:

  • Ivacaftor

Dosage Strength:

  • 50 mg

Pharmaceutical Classes:

  • Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]
  • Chloride Channel Activation Potentiators [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 51167-200 Kalydeco 150 mg Oral Tablet by Vertex Pharmaceuticals Incorporated
  • 51167-400 Kalydeco 75 mg Oral Granule by Vertex Pharmaceuticals Incorporated
  • 51167-600 Kalydeco 25 mg Oral Granule by Vertex Pharmaceuticals Incorporated


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