FDA.reportPublic FDA data

Juxtapid

Product NDC
76431-105
11-digit product format
764310105
Labeler code
76431
Product ID
76431-105_9404d970-ee07-43d7-8fa8-30e45b08087b
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
0000-00-00
Substance
LOMITAPIDE MESYLATE
Active strength
5 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
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
76431-105-01Juxtapid28 in 1 BOTTLECAPSULE2823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76431-105-01EA - Each76431-1055a2f5897-228b-42a3-9647-10f1a82b3e7812013-02-13

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
76431-105JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AMRYT PHARMACEUTICALS DAC]22Legacy 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
76431-105-017643101050128 CAPSULE in 1 BOTTLE (76431-105-01) 28 capsule2013-01-280000-00-00NoNoCurrent