51167-700 : Orkambi Oral Tablet, Film Coated


NDC: 51167-700
Labeler: Vertex Pharmaceuticals Incorporated
Product Type: Human Prescription Drug
Drug Name:  Orkambi
Dosage Form: Oral Tablet, Film Coated
Application #: NDA206038
Rev. Date: 


Appearance:


Markings: 1V125
Shapes:  Oval
Colors:  Pink
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:

  • 51167-700-02: 4 CARTON IN 1 BOX (51167‑700‑02) > 7 BLISTER PACK IN 1 CARTON > 4 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Ivacaftor
  • Lumacaftor

Dosage Strength:

  • 125 mg
  • 100 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Hypromellose Acetate Succinate 06081224 (3 Mm2/S)
  • Magnesium Stearate
  • Povidone, Unspecified
  • Sodium Lauryl Sulfate
  • Carminic Acid
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol, Unspecified
  • 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 2B6 Inducers [MoA]
  • Cytochrome P450 2C19 Inducers [MoA]
  • Cytochrome P450 2C8 Inducers [MoA]
  • Cytochrome P450 2C8 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inducers [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Cytochrome P450 3A Inhibitors [MoA]
  • P-Glycoprotein Inducers [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 51167-122 Orkambi Oral Granule by Vertex Pharmaceuticals Incorporated
  • 51167-500 Orkambi Oral Granule by Vertex Pharmaceuticals Incorporated
  • 51167-809 Orkambi Oral Tablet, Film Coated by Vertex Pharmaceuticals Incorporated
  • 51167-900 Orkambi Oral Granule by Vertex Pharmaceuticals Incorporated

NDC QR Code

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NDC 51167-700 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.