51167-200 : Kalydeco 150 mg Oral Tablet


NDC51167-200
Labeler: Vertex Pharmaceuticals Incorporated
Product Type: Human Prescription Drug
Drug Name:  Kalydeco
Dosage Form: Oral Tablet, Film Coated
Application #: NDA203188
Rev. Date: 


Appearance:


Markings: V;150
Shapes:  Oval
Colors:  Blue
Size (mm): 5
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:

  • 51167-200-01: 4 BLISTER PACK IN 1 CARTON (51167‑200‑01) > 14 TABLET, FILM COATED IN 1 BLISTER PACK
  • 51167-200-02: 1 BOTTLE IN 1 CARTON (51167‑200‑02) > 60 TABLET, FILM COATED IN 1 BOTTLE

Active Ingredients:

  • Ivacaftor

Dosage Strength:

  • 150 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromellose Acetate Succinate 06081224 (3 Mm2/S)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Sodium Lauryl Sulfate
  • Carnauba Wax
  • Fd&c Blue No. 2
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide
  • Ammonia
  • Ferrosoferric Oxide
  • Propylene Glycol
  • Shellac

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.
  • 51167-300 Kalydeco 50 mg Oral Granule 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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