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

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	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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N203858-001	7932268	2027-08-19	U-1316	2013-01-14
N203858-001	12472172	2041-07-29	U-4438	2026-03-25
N203858-002	7932268	2027-08-19	U-1316
N203858-002	12472172	2041-07-29	U-4438	2026-03-25
N203858-003	7932268	2027-08-19	U-1316
N203858-003	12472172	2041-07-29	U-4438	2026-03-25
N203858-004	7932268	2027-08-19	U-1316	2015-05-29
N203858-004	12472172	2041-07-29	U-4438	2026-03-25
N203858-005	7932268	2027-08-19	U-1316	2015-05-29
N203858-006	7932268	2027-08-19	U-1316	2015-05-29
N203858-007	7932268	2027-08-19	U-1316	2026-03-27
N203858-007	12472172	2041-07-29	U-4438	2026-03-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203858-001	NPP	2029-02-25
N203858-002	NPP	2029-02-25
N203858-003	NPP	2029-02-25
N203858-004	NPP	2029-02-25
N203858-005	NPP	2029-02-25
N203858-007	NS	2029-02-25

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203858-001	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-002	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-003	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-004	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-005	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-006	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203858-001	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-002	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-003	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-004	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-005	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-006	ODE-36	2019-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203858-001	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-002	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-003	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-004	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-005	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-006	ODE-36	2019-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203858-001	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-002	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-003	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-004	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-005	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-006	ODE-36	2019-12-21	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-001	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-002	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-003	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-004	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-005	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-007	NS	2029-02-25	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Juxtapid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOMITAPIDE MESYLATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4S83CP54E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1364484	Internal RxNorm lookup
1364490	Internal RxNorm lookup
1364492	Internal RxNorm lookup
1364494	Internal RxNorm lookup
1364496	Internal RxNorm lookup
1364498	Internal RxNorm lookup
1648770	Internal RxNorm lookup
1648772	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e4c45bb5-15f4-437e-ab98-a649b3676d14	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
db1e0578-c863-24bf-85ef-9cbb5c541fbd	Product name	2	20150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76431-110-01	Juxtapid	28 in 1 BOTTLE	CAPSULE	28		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76431-110-01	EA - Each	76431-110	dbfcc24d-1d04-4e16-bf9b-a2c61afe1e8c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LOMITAPIDE MESYLATE	ACTIVE INGREDIENT	X4S83CP54E	JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AEGERION PHARMACEUTICALS, INC.]	12
LOMITAPIDE	ACTIVE MOIETY	82KUB0583F	JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AEGERION PHARMACEUTICALS, INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76431-110	JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [AMRYT PHARMACEUTICALS DAC]	22	Current NDC, Legacy NDC, 1 package rows	20220430_e4c45bb5-15f4-437e-ab98-a649b3676d14.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Juxtapid	LOMITAPIDE MESYLATE	Chiesi USA, Inc.	61a0be9d-ee58-43e0-b5cb-141011835081	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203858 application number: NDA203858
Juxtapid	LOMITAPIDE MESYLATE	Amryt Pharmaceuticals DAC	e4c45bb5-15f4-437e-ab98-a649b3676d14	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203858 application number: NDA203858 ndc (product): 76431-110

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4S83CP54E	LOMITAPIDE MESYLATE	202914-84-9	LOMITAPIDE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1364490	Juxtapid 10 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364494	Juxtapid 20 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648772	Juxtapid 30 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364498	Juxtapid 5 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364484	lomitapide 10 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364492	lomitapide 20 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648770	lomitapide 30 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364496	lomitapide 5 MG Oral Capsule	PSN	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364490	lomitapide 10 MG Oral Capsule [Juxtapid]	SBD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364494	lomitapide 20 MG Oral Capsule [Juxtapid]	SBD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648772	lomitapide 30 MG Oral Capsule [Juxtapid]	SBD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364498	lomitapide 5 MG Oral Capsule [Juxtapid]	SBD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364484	lomitapide 10 MG Oral Capsule	SCD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364492	lomitapide 20 MG Oral Capsule	SCD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648770	lomitapide 30 MG Oral Capsule	SCD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364496	lomitapide 5 MG Oral Capsule	SCD	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364490	Juxtapid (as lomitapide mesylate) 10 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364494	Juxtapid (as lomitapide mesylate) 20 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364498	Juxtapid (as lomitapide mesylate) 5 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364490	Juxtapid 10 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364494	Juxtapid 20 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648772	Juxtapid 30 MG (as lomitapide mesylate) Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648772	Juxtapid 30 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364498	Juxtapid 5 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364484	lomitapide (as lomitapide mesylate) 10 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364492	lomitapide (as lomitapide mesylate) 20 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1364496	lomitapide (as lomitapide mesylate) 5 MG Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23
1648770	lomitapide 30 MG (as lomitapide mesylate) Oral Capsule	SY	e4c45bb5-15f4-437e-ab98-a649b3676d14	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76431-110-01	76431011001	28 CAPSULE in 1 BOTTLE (76431-110-01)	28 capsule	2013-01-28	2027-01-03	No	No	Current