NDC 51167-500

ORKAMBI

Lumacaftor And Ivacaftor

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

• Product ID: 51167-500_2412d19f-9f31-49f3-a7f9-f44db330fcf7
• NDC: 51167-500
• Product Type: Human Prescription Drug
• Proprietary Name: ORKAMBI
• Generic Name: Lumacaftor And Ivacaftor
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-07
• Marketing Category: NDA / NDA
• Application Number: NDA211358
• Labeler Name: Vertex Pharmaceuticals Incorporated
• Substance Name: IVACAFTOR; LUMACAFTOR
• Active Ingredient Strength: 188 mg/1; mg/1
• Pharm 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 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 51167-500-02

56 PACKET in 1 CARTON (51167-500-02) > 1 GRANULE in 1 PACKET

• Marketing Start Date: 2018-08-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51167-500-02 [51167050002]

ORKAMBI GRANULE

• Marketing Category: NDA
• Application Number: NDA211358
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-07

Drug Details

Active Ingredients

Ingredient	Strength
LUMACAFTOR	150 mg/1

OpenFDA Data

• SPL SET ID: 3fc1c40e-cfac-47a1-9e1a-61ead3570600
• Manufacturer:
  • Vertex Pharmaceuticals Incorporated
• UNII:
  • 1Y740ILL1Z
  • EGP8L81APK
• RxNorm Concept Unique ID - RxCUI:
  • 1655928
  • 2053519
  • 2053509
  • 1655934
  • 1812470
  • 2053512
  • 2053517
  • 1812468

Pharmacological Class

• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C8 Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• P-Glycoprotein Inducers [MoA]
• P-Glycoprotein Inhibitors [MoA]
• 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 "ORKAMBI" or generic name "Lumacaftor And Ivacaftor"

NDC	Brand Name	Generic Name
51167-122	ORKAMBI	lumacaftor and ivacaftor
51167-500	ORKAMBI	lumacaftor and ivacaftor
51167-700	ORKAMBI	lumacaftor and ivacaftor
51167-809	ORKAMBI	lumacaftor and ivacaftor
51167-900	ORKAMBI	lumacaftor and ivacaftor