FDA.reportPublic FDA data

Juxtapid

Product NDC
76431-110
11-digit product format
764310110
Labeler code
76431
Product ID
76431-110_76014f22-a52f-486b-a265-177b6403c907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lomitapide mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Amryt Pharmaceuticals DAC
Application
NDA203858
Marketing category
NDA
Marketing start
2013-01-03
Marketing end
2027-01-03
Substance
LOMITAPIDE MESYLATE
Active strength
10 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Juxtapid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOMITAPIDE MESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4S83CP54E
Rxcui1364484, 1364490, 1364492, 1364494, 1364496, 1364498, 1648770, 1648772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
db1e0578-c863-24bf-85ef-9cbb5c541fbdProduct name220150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76431-110-01Juxtapid28 in 1 BOTTLECAPSULE2823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76431-110-01EA - Each76431-110dbfcc24d-1d04-4e16-bf9b-a2c61afe1e8c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOMITAPIDE MESYLATEACTIVE INGREDIENTX4S83CP54EJUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AEGERION PHARMACEUTICALS, INC.]12
LOMITAPIDEACTIVE MOIETY82KUB0583FJUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AEGERION PHARMACEUTICALS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76431-110JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AMRYT PHARMACEUTICALS DAC]22Current NDC, Legacy NDC, 1 package rows20220430_e4c45bb5-15f4-437e-ab98-a649b3676d14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364490Juxtapid 10 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364494Juxtapid 20 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648772Juxtapid 30 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364498Juxtapid 5 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364484lomitapide 10 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364492lomitapide 20 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648770lomitapide 30 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364496lomitapide 5 MG Oral CapsulePSNe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364490lomitapide 10 MG Oral Capsule [Juxtapid]SBDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364494lomitapide 20 MG Oral Capsule [Juxtapid]SBDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648772lomitapide 30 MG Oral Capsule [Juxtapid]SBDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364498lomitapide 5 MG Oral Capsule [Juxtapid]SBDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364484lomitapide 10 MG Oral CapsuleSCDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364492lomitapide 20 MG Oral CapsuleSCDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648770lomitapide 30 MG Oral CapsuleSCDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364496lomitapide 5 MG Oral CapsuleSCDe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364490Juxtapid (as lomitapide mesylate) 10 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364494Juxtapid (as lomitapide mesylate) 20 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364498Juxtapid (as lomitapide mesylate) 5 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364490Juxtapid 10 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364494Juxtapid 20 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648772Juxtapid 30 MG (as lomitapide mesylate) Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648772Juxtapid 30 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364498Juxtapid 5 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364484lomitapide (as lomitapide mesylate) 10 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364492lomitapide (as lomitapide mesylate) 20 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1364496lomitapide (as lomitapide mesylate) 5 MG Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423
1648770lomitapide 30 MG (as lomitapide mesylate) Oral CapsuleSYe4c45bb5-15f4-437e-ab98-a649b3676d1423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76431-110-017643101100128 CAPSULE in 1 BOTTLE (76431-110-01) 28 capsule2013-01-282027-01-03NoNoCurrent