ing End Date
1 NDC:76431-110-01 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:76431-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F) LOMITAPIDE 20 mg
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A733;20mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76431-120-01 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:76431-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F) LOMITAPIDE 30 mg
Product Characteristics
Color YELLOW, ORANGE (Swedish Orange) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code A733;30mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76431-130-01 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:76431-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOMITAPIDE MESYLATE (UNII: X4S83CP54E) (LOMITAPIDE - UNII:82KUB0583F) LOMITAPIDE 40 mg
Product Characteristics
Color WHITE, YELLOW Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code A733;40mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76431-140-01 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:76431-160
Route of Administration ORAL DEA Schedule
Ac