juxtapid

Generic: lomitapide mesylate

Labeler: amryt pharmaceuticals dac
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name juxtapid
Generic Name lomitapide mesylate
Labeler amryt pharmaceuticals dac
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lomitapide mesylate 10 mg/1

Manufacturer
Amryt Pharmaceuticals DAC

Identifiers & Regulatory

Product NDC 76431-110
Product ID 76431-110_76014f22-a52f-486b-a265-177b6403c907
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203858
Marketing Start 2013-01-03
Marketing End 2027-01-03

Pharmacologic Class

Classes
cytochrome p450 3a4 inhibitors [moa] microsomal triglyceride transfer protein inhibitor [epc] microsomal triglyceride transfer protein inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76431110
Hyphenated Format 76431-110

Supplemental Identifiers

RxCUI
1364484 1364490 1364492 1364494 1364496 1364498 1648770 1648772
UNII
X4S83CP54E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name juxtapid (source: ndc)
Generic Name lomitapide mesylate (source: ndc)
Application Number NDA203858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (76431-110-01)
source: ndc

Packages (1)

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

Ingredients (1)

lomitapide mesylate (10 mg/1)

Linked Drug Pages (1)

Juxtapid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "76014f22-a52f-486b-a265-177b6403c907", "openfda": {"unii": ["X4S83CP54E"], "rxcui": ["1364484", "1364490", "1364492", "1364494", "1364496", "1364498", "1648770", "1648772"], "spl_set_id": ["e4c45bb5-15f4-437e-ab98-a649b3676d14"], "manufacturer_name": ["Amryt Pharmaceuticals DAC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (76431-110-01)", "package_ndc": "76431-110-01", "marketing_end_date": "20270103", "marketing_start_date": "20130128"}], "brand_name": "Juxtapid", "product_id": "76431-110_76014f22-a52f-486b-a265-177b6403c907", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Microsomal Triglyceride Transfer Protein Inhibitor [EPC]", "Microsomal Triglyceride Transfer Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "76431-110", "generic_name": "lomitapide mesylate", "labeler_name": "Amryt Pharmaceuticals DAC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Juxtapid", "active_ingredients": [{"name": "LOMITAPIDE MESYLATE", "strength": "10 mg/1"}], "application_number": "NDA203858", "marketing_category": "NDA", "marketing_end_date": "20270103", "marketing_start_date": "20130103"}