NDC 76431-110

Juxtapid

Lomitapide Mesylate

Juxtapid is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amryt Pharmaceutcials Dac. The primary component is Lomitapide Mesylate.

• Product ID: 76431-110_3eb234ce-0275-40fa-86dd-2f98eaf88c15
• NDC: 76431-110
• Product Type: Human Prescription Drug
• Proprietary Name: Juxtapid
• Generic Name: Lomitapide Mesylate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-03
• Marketing Category: NDA / NDA
• Application Number: NDA203858
• Labeler Name: Amryt Pharmaceutcials DAC
• Substance Name: LOMITAPIDE MESYLATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 76431-110-01

28 CAPSULE in 1 BOTTLE (76431-110-01)

• Marketing Start Date: 2013-01-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76431-110-01 [76431011001]

Juxtapid CAPSULE

• Marketing Category: NDA
• Application Number: NDA203858
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-28

Drug Details

Active Ingredients

Ingredient	Strength
LOMITAPIDE MESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: e4c45bb5-15f4-437e-ab98-a649b3676d14
• Manufacturer:
  • Aegerion Pharmaceuticals, Inc.
• UNII:
  • X4S83CP54E
• RxNorm Concept Unique ID - RxCUI:
  • 1364496
  • 1364494
  • 1648780
  • 1364492
  • 1648778
  • 1364490
  • 1648776
  • 1648774
  • 1648772
  • 1364498
  • 1648770
  • 1364484
• UPC Code:
  • 0376431105011
  • 0376431110015
  • 0376431120014

Pharmacological Class

• Microsomal Triglyceride Transfer Protein Inhibitor [EPC]
• Microsomal Triglyceride Transfer Protein Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "Juxtapid" or generic name "Lomitapide Mesylate"

NDC	Brand Name	Generic Name
76431-105	Juxtapid	lomitapide mesylate
76431-110	Juxtapid	lomitapide mesylate
76431-120	Juxtapid	lomitapide mesylate
76431-130	Juxtapid	lomitapide mesylate
76431-140	Juxtapid	lomitapide mesylate
76431-160	Juxtapid	lomitapide mesylate