Signifor LAR

Product NDC: 0078-0643
11-digit product format: 000780643
Labeler code: 0078
Product ID: 0078-0643_4253d26f-71c0-4c7c-8459-f238841f92b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pasireotide
Dosage form: KIT
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA203255
Marketing category: NDA
Marketing start: 2014-12-15
Marketing end: 2022-09-30
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0078-0643		D	Discontinued by firm		2026-08-11
excluded package	package	0078-0643	0078-0643-81	D	Discontinued by firm		2026-08-11

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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`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	0078-0643-81	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N203255-001	SIGNIFOR LAR KIT	PASIREOTIDE PAMOATE	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15
N203255-002	SIGNIFOR LAR KIT	PASIREOTIDE PAMOATE	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15
N203255-003	SIGNIFOR LAR KIT	PASIREOTIDE PAMOATE	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15
N203255-004	SIGNIFOR LAR KIT	PASIREOTIDE PAMOATE	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29
N203255-005	SIGNIFOR LAR KIT	PASIREOTIDE PAMOATE	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N203255-001	7759308	2026-10-25	Drug product	2015-01-13
N203255-001	7473761	2026-12-14	Drug substance, Drug product	2015-01-13
N203255-001	9351923	2028-05-23	Drug product	2017-11-13
N203255-002	7759308	2026-10-25	Drug product	2015-01-13
N203255-002	7473761	2026-12-14	Drug substance, Drug product	2015-01-13
N203255-002	9351923	2028-05-23	Drug product	2017-11-13
N203255-003	7759308	2026-10-25	Drug product	2015-01-13
N203255-003	7473761	2026-12-14	Drug substance, Drug product	2015-01-13
N203255-003	9351923	2028-05-23	Drug product	2017-11-13
N203255-004	7759308	2026-10-25	Drug product	2019-09-11
N203255-004	7473761	2026-12-14	Drug substance, Drug product	2019-09-11
N203255-004	9351923	2028-05-23	Drug product	2019-09-11
N203255-005	7759308	2026-10-25	Drug product	2019-09-11
N203255-005	7473761	2026-12-14	Drug substance, Drug product	2019-09-11
N203255-005	9351923	2028-05-23	Drug product	2019-09-11

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 6 · 205 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	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-001	SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-002	SIGNIFOR LAR KIT	EQ 40MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2014-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-003	SIGNIFOR LAR KIT	EQ 60MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2014-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-004	SIGNIFOR LAR KIT	EQ 10MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-005	SIGNIFOR LAR KIT	EQ 30MG BASE/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-06-29	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 681 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203255-001	7759308	2026-10-25	Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-001	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-001	9351923	2028-05-23	Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-002	7759308	2026-10-25	Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-002	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-002	9351923	2028-05-23	Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-003	7759308	2026-10-25	Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-003	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-003	9351923	2028-05-23	Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-004	7759308	2026-10-25	Drug product	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-004	7473761	2026-12-14	Drug substance, Drug product	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-004	9351923	2028-05-23	Drug product	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-005	7759308	2026-10-25	Drug product	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-005	7473761	2026-12-14	Drug substance, Drug product	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203255-005	9351923	2028-05-23	Drug product	2019-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-001	7759308	2026-10-25	Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-001	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-001	9351923	2028-05-23	Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-002	7759308	2026-10-25	Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-002	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-002	9351923	2028-05-23	Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-003	7759308	2026-10-25	Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-003	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-003	9351923	2028-05-23	Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-004	7759308	2026-10-25	Drug product	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-004	7473761	2026-12-14	Drug substance, Drug product	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-004	9351923	2028-05-23	Drug product	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-005	7759308	2026-10-25	Drug product	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-005	7473761	2026-12-14	Drug substance, Drug product	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-005	9351923	2028-05-23	Drug product	2019-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203255-001	7759308	2026-10-25	Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-001	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-001	9351923	2028-05-23	Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-002	7759308	2026-10-25	Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-002	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-002	9351923	2028-05-23	Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-003	7759308	2026-10-25	Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-003	7473761	2026-12-14	Drug substance, Drug product	2015-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-003	9351923	2028-05-23	Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-004	7759308	2026-10-25	Drug product	2019-09-11	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-001	ODE-268	2025-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-002	ODE-268	2025-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-003	ODE-268	2025-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-004	ODE-268	2025-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203255-005	ODE-268	2025-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203255-001	ODE-268	2025-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-002	ODE-268	2025-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-003	ODE-268	2025-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-004	ODE-268	2025-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203255-005	ODE-268	2025-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-001	ODE-268	2025-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-002	ODE-268	2025-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-003	ODE-268	2025-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-004	ODE-268	2025-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203255-005	ODE-268	2025-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-001	ODE-268	2025-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-002	ODE-268	2025-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-003	ODE-268	2025-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-004	ODE-268	2025-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203255-005	ODE-268	2025-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-001	ODE-268	2025-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-002	ODE-268	2025-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-003	ODE-268	2025-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-004	ODE-268	2025-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203255-005	ODE-268	2025-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-001	ODE-268	2025-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-002	ODE-268	2025-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-003	ODE-268	2025-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-004	ODE-268	2025-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203255-005	ODE-268	2025-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-001	ODE-268	2025-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-002	ODE-268	2025-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-003	ODE-268	2025-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-004	ODE-268	2025-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203255-005	ODE-268	2025-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203255-001	ODE-268	2025-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203255-002	ODE-268	2025-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203255-003	ODE-268	2025-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203255-004	ODE-268	2025-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203255-005	ODE-268	2025-06-29	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0643-61	EA - Each	0078-0643	ea6b32df-5bb5-4ac0-b0e2-fa051387d5ea	1	2015-03-03
0078-0643-81	EA - Each	0078-0643	5dc8aa66-1b71-4ede-9fee-98f8f1568086	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PASIREOTIDE	ACTIVE INGREDIENT	98H1T17066	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
PASIREOTIDE	ACTIVE MOIETY	98H1T17066	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW)	INACTIVE INGREDIENT	WE369X5600	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW)	INACTIVE INGREDIENT	QD923V64H3	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SIGNIFOR LAR (PASIREOTIDE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	2

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
Signifor LAR	PASIREOTIDE	Recordati Rare Diseases, Inc.	a0aad470-3f38-af97-e053-2995a90a383a	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203255 application number: NDA203255

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98H1T17066	PASIREOTIDE	396091-73-9	pasireotide

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0643-81	00078064381	1 KIT in 1 KIT (0078-0643-81) * 6 mL in 1 VIAL, SINGLE-USE (0078-0783-61) * 2 mL in 1 SYRINGE	1 kit	2014-12-15	0000-00-00	No	No	Current