National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:24:08

Label at a glance#

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76431-110	76431-110-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 261 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD, RS	2015-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-007	JUXTAPID	EQ 2MG BASE	CAPSULE / ORAL	RLD	2026-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD, RS	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	JUXTAPID	EQ 2MG BASE	CAPSULE / ORAL	RLD	2026-02-25	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,950 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203858-001	7932268	2027-08-19	U-1316	2013-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-001	12472172	2041-07-29	U-4438	2026-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-002	7932268	2027-08-19	U-1316		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-002	12472172	2041-07-29	U-4438	2026-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-003	7932268	2027-08-19	U-1316		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-003	12472172	2041-07-29	U-4438	2026-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-004	7932268	2027-08-19	U-1316	2015-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-004	12472172	2041-07-29	U-4438	2026-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-005	7932268	2027-08-19	U-1316	2015-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-006	7932268	2027-08-19	U-1316	2015-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-007	7932268	2027-08-19	U-1316	2026-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-007	12472172	2041-07-29	U-4438	2026-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203858-001	7932268	2027-08-19	U-1316	2013-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-001	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	7932268	2027-08-19	U-1316		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	7932268	2027-08-19	U-1316		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-006	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	7932268	2027-08-19	U-1316	2026-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N203858-001	NPP	2029-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-002	NPP	2029-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-003	NPP	2029-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-004	NPP	2029-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-005	NPP	2029-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203858-007	NS	2029-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203858-001	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	NS	2029-02-25	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Juxtapid	LOMITAPIDE MESYLATE	Amryt Pharmaceuticals DAC	e4c45bb5-15f4-437e-ab98-a649b3676d14	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 76431-110-01 ndc11 (package): 76431011001

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.