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 ID: 51167-300_25c64c24-14ff-443e-a93e-f8cef278caa0
• NDC: 51167-300
• Product Type: Human Prescription Drug
• Proprietary Name: Kalydeco
• Generic Name: Ivacaftor
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-23
• Marketing Category: NDA / NDA
• Application Number: NDA207925
• Labeler Name: Vertex Pharmaceuticals Incorporated
• Substance Name: IVACAFTOR
• Active Ingredient Strength: 50 mg/1
• Pharm 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51167-300-01

56 GRANULE in 1 CARTON (51167-300-01)

• Marketing Start Date: 2015-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51167-300-01 [51167030001]

Kalydeco GRANULE

• Marketing Category: NDA
• Application Number: NDA207925
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-23

Drug Details

Active Ingredients

Ingredient	Strength
IVACAFTOR	50 mg/1

OpenFDA Data

• SPL SET ID: 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25
• Manufacturer:
  • Vertex Pharmaceuticals Incorporated
• UNII:
  • 1Y740ILL1Z
• 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"

NDC	Brand Name	Generic Name
51167-200	Kalydeco	ivacaftor
51167-300	Kalydeco	ivacaftor
51167-400	Kalydeco	ivacaftor
51167-600	Kalydeco	ivacaftor