Home NDC 75929-172-25 Juxtapid
Product NDC 75929-172
Requested package NDC 75929-172-25
11-digit product format 759290172
Labeler code 75929
Product ID 75929-172_4b213a81-7f56-a734-e063-6394a90a07e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lomitapide mesylate
Dosage form CAPSULE
Route ORAL
Labeler Pharma Packaging Solutions, LLC dba Tjoapack LLC
Application NDA203858
Marketing category NDA
Marketing start 2013-01-03
Substance LOMITAPIDE MESYLATE
Active strength 30 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 2027-12-31
Current FDA listing Yes 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75929-172-25 75929017225 28 CAPSULE in 1 BOTTLE (75929-172-25) 28 capsule 2015-06-22 No No Historical