NDC 51167-300

Kalydeco

Ivacaftor

Kalydeco is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Vertex Pharmaceuticals Incorporated. The primary component is Ivacaftor.

Product ID51167-300_25c64c24-14ff-443e-a93e-f8cef278caa0
NDC51167-300
Product TypeHuman Prescription Drug
Proprietary NameKalydeco
Generic NameIvacaftor
Dosage FormGranule
Route of AdministrationORAL
Marketing Start Date2015-03-23
Marketing CategoryNDA / NDA
Application NumberNDA207925
Labeler NameVertex Pharmaceuticals Incorporated
Substance NameIVACAFTOR
Active Ingredient Strength50 mg/1
Pharm ClassesCystic 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]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51167-300-01

56 GRANULE in 1 CARTON (51167-300-01)
Marketing Start Date2015-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51167-300-01 [51167030001]

Kalydeco GRANULE
Marketing CategoryNDA
Application NumberNDA207925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-23

Drug Details

Active Ingredients

IngredientStrength
IVACAFTOR50 mg/1

OpenFDA Data

SPL SET ID:0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1606862
  • 1606870
  • 1606866
  • 1606868
  • 1243046
  • 1243052
  • UPC Code
  • 0066675000080
  • Pharmacological Class

    • 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]

    NDC Crossover Matching brand name "Kalydeco" or generic name "Ivacaftor"

    NDCBrand NameGeneric Name
    51167-200Kalydecoivacaftor
    51167-300Kalydecoivacaftor
    51167-400Kalydecoivacaftor
    51167-600Kalydecoivacaftor

    Trademark Results [Kalydeco]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KALYDECO
    KALYDECO
    85585659 4245428 Live/Registered
    Vertex Pharmaceuticals Incorporated
    2012-03-31
    KALYDECO
    KALYDECO
    85155478 4147369 Live/Registered
    Vertex Pharmaceuticals Incorporated
    2010-10-18

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