Home NDC 76431-160 Juxtapid
Product NDC 76431-160
11-digit product format 764310160
Labeler code 76431
Product ID 76431-160_84e6a877-ee70-4add-994e-380ef190ccfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lomitapide mesylate
Dosage form CAPSULE
Route ORAL
Labeler Aegerion Pharmaceuticals, Inc.
Application NDA203858
Marketing category NDA
Marketing start 2013-01-03
Marketing end 0000-00-00
Substance LOMITAPIDE MESYLATE
Active strength 60 mg/1
Pharmacologic classes Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76431-160-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76431-160-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76431-160-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76431-160-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76431-160-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76431-160-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76431-160-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76431-160-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76431-160-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76431-160-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 76431-160-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 76431-160-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203858-001 JUXTAPID LOMITAPIDE MESYLATE EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 N203858-002 JUXTAPID LOMITAPIDE MESYLATE EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 N203858-003 JUXTAPID LOMITAPIDE MESYLATE EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 N203858-004 JUXTAPID LOMITAPIDE MESYLATE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2015-04-23 N203858-005 JUXTAPID LOMITAPIDE MESYLATE EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 N203858-006 JUXTAPID LOMITAPIDE MESYLATE EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 N203858-007 JUXTAPID LOMITAPIDE MESYLATE EQ 2MG BASE CAPSULE / ORAL RLD 2026-02-25
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 7 · 247 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-005 JUXTAPID EQ 40MG BASE CAPSULE / ORAL RLD 2015-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203858-006 JUXTAPID EQ 60MG BASE CAPSULE / ORAL RLD 2015-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203858-001 JUXTAPID EQ 5MG BASE CAPSULE / ORAL RLD 2012-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203858-002 JUXTAPID EQ 10MG BASE CAPSULE / ORAL RLD 2012-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203858-003 JUXTAPID EQ 20MG BASE CAPSULE / ORAL RLD 2012-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203858-004 JUXTAPID EQ 30MG BASE CAPSULE / ORAL RLD 2015-04-23 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 49 · 1,926 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203858-001 7932268 2027-08-19 U-1316 2013-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-002 7932268 2027-08-19 U-1316 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-003 7932268 2027-08-19 U-1316 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-004 7932268 2027-08-19 U-1316 2015-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-005 7932268 2027-08-19 U-1316 2015-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203858-006 7932268 2027-08-19 U-1316 2015-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 10016404 2025-03-07 U-1316 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 10555938 2025-03-07 U-1316 2020-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 8618135 2025-03-07 U-1316 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 9265758 2025-03-07 U-1316 2016-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 9364470 2025-03-07 U-1851 2016-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 9433617 2025-03-07 U-1316 2016-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 9861622 2025-03-07 U-1316 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-001 7932268 2027-08-19 U-1316 2013-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 10016404 2025-03-07 U-1316 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 10555938 2025-03-07 U-1316 2020-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 8618135 2025-03-07 U-1316 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 9265758 2025-03-07 U-1316 2016-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 9364470 2025-03-07 U-1851 2016-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 9433617 2025-03-07 U-1316 2016-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 9861622 2025-03-07 U-1316 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-002 7932268 2027-08-19 U-1316 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 10016404 2025-03-07 U-1316 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 10555938 2025-03-07 U-1316 2020-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 8618135 2025-03-07 U-1316 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 9265758 2025-03-07 U-1316 2016-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 9364470 2025-03-07 U-1851 2016-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 9433617 2025-03-07 U-1316 2016-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 9861622 2025-03-07 U-1316 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-003 7932268 2027-08-19 U-1316 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 10016404 2025-03-07 U-1316 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 10555938 2025-03-07 U-1316 2020-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 8618135 2025-03-07 U-1316 2015-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 9265758 2025-03-07 U-1316 2016-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 9364470 2025-03-07 U-1851 2016-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 9433617 2025-03-07 U-1316 2016-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 9861622 2025-03-07 U-1316 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-004 7932268 2027-08-19 U-1316 2015-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-005 10016404 2025-03-07 U-1316 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203858-005 10555938 2025-03-07 U-1316 2020-04-28 31067a03dcf5…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.