51167-200 : Kalydeco 150 mg Oral Tablet


NDC: 51167-200
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:

  • Chloride Channel Activation Potentiators [MoA]
  • Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitors [MoA]
  • P-Glycoprotein 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
  • 51167-770 Kalydeco 13.4 mg Oral Granule by Vertex Pharmaceuticals Incorporated
  • 51167-785 Kalydeco 5.8 mg Oral Granule by Vertex Pharmaceuticals Incorporated

NDC QR Code

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NDC 51167-200 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.