Juxtapid

Product NDC
75929-172
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75929-172DDiscontinued by firm2026-08-03
excluded packagepackage75929-17275929-172-25DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203858-001JUXTAPIDLOMITAPIDE MESYLATEEQ 5MG BASECAPSULE / ORALRLD2012-12-21
N203858-002JUXTAPIDLOMITAPIDE MESYLATEEQ 10MG BASECAPSULE / ORALRLD2012-12-21
N203858-003JUXTAPIDLOMITAPIDE MESYLATEEQ 20MG BASECAPSULE / ORALRLD2012-12-21
N203858-004JUXTAPIDLOMITAPIDE MESYLATEEQ 30MG BASECAPSULE / ORALRLD, RS2015-04-23
N203858-005JUXTAPIDLOMITAPIDE MESYLATEEQ 40MG BASECAPSULE / ORALRLD2015-04-23
N203858-006JUXTAPIDLOMITAPIDE MESYLATEEQ 60MG BASECAPSULE / ORALRLD2015-04-23
N203858-007JUXTAPIDLOMITAPIDE MESYLATEEQ 2MG BASECAPSULE / ORALRLD2026-02-25

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203858-00179322682027-08-19U-13162013-01-14
N203858-001124721722041-07-29U-44382026-03-25
N203858-00279322682027-08-19U-1316
N203858-002124721722041-07-29U-44382026-03-25
N203858-00379322682027-08-19U-1316
N203858-003124721722041-07-29U-44382026-03-25
N203858-00479322682027-08-19U-13162015-05-29
N203858-004124721722041-07-29U-44382026-03-25
N203858-00579322682027-08-19U-13162015-05-29
N203858-00679322682027-08-19U-13162015-05-29
N203858-00779322682027-08-19U-13162026-03-27
N203858-007124721722041-07-29U-44382026-03-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203858-001NPP2029-02-25
N203858-002NPP2029-02-25
N203858-003NPP2029-02-25
N203858-004NPP2029-02-25
N203858-005NPP2029-02-25
N203858-007NS2029-02-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-005JUXTAPIDEQ 40MG BASECAPSULE / ORALRLD2015-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203858-006JUXTAPIDEQ 60MG BASECAPSULE / ORALRLD2015-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203858-001JUXTAPIDEQ 5MG BASECAPSULE / ORALRLD2012-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203858-002JUXTAPIDEQ 10MG BASECAPSULE / ORALRLD2012-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203858-003JUXTAPIDEQ 20MG BASECAPSULE / ORALRLD2012-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203858-004JUXTAPIDEQ 30MG BASECAPSULE / ORALRLD2015-04-232680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,926 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203858-00179322682027-08-19U-13162013-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-00279322682027-08-19U-1316011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-00379322682027-08-19U-1316011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-00479322682027-08-19U-13162015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-00579322682027-08-19U-13162015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203858-00679322682027-08-19U-13162015-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-001100164042025-03-07U-13162018-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-001105559382025-03-07U-13162020-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00186181352025-03-07U-13162014-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00192657582025-03-07U-13162016-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00193644702025-03-07U-18512016-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00194336172025-03-07U-13162016-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00198616222025-03-07U-13162018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00179322682027-08-19U-13162013-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-002100164042025-03-07U-13162018-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-002105559382025-03-07U-13162020-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00286181352025-03-07U-13162014-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00292657582025-03-07U-13162016-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00293644702025-03-07U-18512016-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00294336172025-03-07U-13162016-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00298616222025-03-07U-13162018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00279322682027-08-19U-131631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-003100164042025-03-07U-13162018-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-003105559382025-03-07U-13162020-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00386181352025-03-07U-13162014-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00392657582025-03-07U-13162016-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00393644702025-03-07U-18512016-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00394336172025-03-07U-13162016-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00398616222025-03-07U-13162018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00379322682027-08-19U-131631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-004100164042025-03-07U-13162018-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-004105559382025-03-07U-13162020-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00486181352025-03-07U-13162015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00492657582025-03-07U-13162016-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00493644702025-03-07U-18512016-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00494336172025-03-07U-13162016-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00498616222025-03-07U-13162018-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-00479322682027-08-19U-13162015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-005100164042025-03-07U-13162018-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203858-005105559382025-03-07U-13162020-04-2831067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N203858-001ODE-362019-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203858-002ODE-362019-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203858-003ODE-362019-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203858-004ODE-362019-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203858-005ODE-362019-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203858-006ODE-362019-12-2174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N203858-001ODE-362019-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N203858-002ODE-362019-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N203858-003ODE-362019-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N203858-004ODE-362019-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N203858-005ODE-362019-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N203858-006ODE-362019-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N203858-001ODE-362019-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N203858-002ODE-362019-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N203858-003ODE-362019-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N203858-004ODE-362019-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N203858-005ODE-362019-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N203858-006ODE-362019-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N203858-001ODE-362019-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N203858-002ODE-362019-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N203858-003ODE-362019-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N203858-004ODE-362019-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N203858-005ODE-362019-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N203858-006ODE-362019-12-21ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-001NPP2029-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-002NPP2029-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-003NPP2029-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-004NPP2029-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-005NPP2029-02-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203858-007NS2029-02-25a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JuxtapidLOMITAPIDE MESYLATEChiesi USA, Inc.61a0be9d-ee58-43e0-b5cb-1410118350812026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203858
application number: NDA203858
JuxtapidLOMITAPIDE MESYLATEAmryt Pharmaceuticals DACe4c45bb5-15f4-437e-ab98-a649b3676d142026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 203858
application number: NDA203858

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75929-172-257592901722528 CAPSULE in 1 BOTTLE (75929-172-25) 28 capsule2015-06-22NoNoHistorical