MedPath

Juxtapid

These highlights do not include all the information needed to use JUXTAPID safely and effectively. See full prescribing information for JUXTAPID. JUXTAPID (lomitapide) capsules, for oral use Initial U.S. Approval: 2012

Approved
Approval ID

e4c45bb5-15f4-437e-ab98-a649b3676d14

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2022

Manufacturers
FDA

Amryt Pharmaceuticals DAC

DUNS: 985632604

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lomitapide mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76431-105
Application NumberNDA203858
Product Classification
M
Marketing Category
C73594
G
Generic Name
lomitapide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2020
FDA Product Classification

INGREDIENTS (1)

LOMITAPIDE MESYLATEActive
Quantity: 5 mg in 1 1
Code: X4S83CP54E
Classification: ACTIM

lomitapide mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76431-130
Application NumberNDA203858
Product Classification
M
Marketing Category
C73594
G
Generic Name
lomitapide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2020
FDA Product Classification

INGREDIENTS (1)

LOMITAPIDE MESYLATEActive
Quantity: 30 mg in 1 1
Code: X4S83CP54E
Classification: ACTIM

lomitapide mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76431-110
Application NumberNDA203858
Product Classification
M
Marketing Category
C73594
G
Generic Name
lomitapide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2020
FDA Product Classification

INGREDIENTS (1)

LOMITAPIDE MESYLATEActive
Quantity: 10 mg in 1 1
Code: X4S83CP54E
Classification: ACTIM

lomitapide mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76431-120
Application NumberNDA203858
Product Classification
M
Marketing Category
C73594
G
Generic Name
lomitapide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2020
FDA Product Classification

INGREDIENTS (1)

LOMITAPIDE MESYLATEActive
Quantity: 20 mg in 1 1
Code: X4S83CP54E
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.