s shellac, black iron oxide, and propylene glycol.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
JUXTAPID is a registered trademark of Aegerion Pharmaceuticals, Inc.
Manufactured for:
Aegerion Pharmaceuticals, Inc.
Cambridge, MA 02142
04/2015© Aegerion
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PRINCIPAL DISPLAY PANEL
Package Label - Principal Display Panel – 5 mg, 28 ct Capsules
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Package Label - Principal Display Panel – 5 mg, 28 ct Capsule Carton
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Package Label - Principal Display Panel – 10 mg, 28 ct Capsules
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Package Label - Principal Display Panel – 10 mg, 28 ct Capsule Carton
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Package Label - Principal Display Panel – 20 mg, 28 ct Capsules
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Package Label - Principal Display Panel – 20 mg, 28 ct Capsule Carton
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Package Label - Principal Display Panel – 30 mg, 28 ct Capsules
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Package Label - Principal Display Panel – 30 mg, 28 ct Capsule Carton
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Package Label - Principal Display Panel – 40 mg, 28 ct Capsules
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Package Label - Principal Display Panel – 40 mg, 28 ct Capsule Carton
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Package Label - Principal Display Panel – 60 mg, 28 ct Capsules
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INGREDIENTS AND APPEARANCE
JUXTAPID
lomitapide mesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76431-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F) LOMITAPIDE 5 mg
Product Characteristics
Color ORANGE (Swedish Orange) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A733;5mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76431-105-01 28 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203858 01/03/2013
JUXTAPID
lomitapide mesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76431-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F) LOMITAPIDE 10 mg
Product Characteristics
Color ORANGE (Swedish Orange) , WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A733;10mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Market