Signifor LAR

Product NDC: 55292-139
11-digit product format: 552920139
Labeler code: 55292
Product ID: 55292-139_fb5687ef-6bbc-4ac4-899e-46c941f214c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pasireotide
Dosage form: KIT
Labeler: Recordati Rare Diseases, Inc.
Application: NDA203255
Marketing category: NDA
Marketing start: 2014-12-15
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Signifor LAR
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1597596	Internal RxNorm lookup
1597599	Internal RxNorm lookup
1597601	Internal RxNorm lookup
1597603	Internal RxNorm lookup
1597820	Internal RxNorm lookup
1597822	Internal RxNorm lookup
2049730	Internal RxNorm lookup
2049732	Internal RxNorm lookup
2049734	Internal RxNorm lookup
2049736	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
a0aad470-3f38-af97-e053-2995a90a383a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
093f5f72-95bf-45e6-8f9d-fb29c1364d06	Product name	2	20180817

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55292-139-01	2025-08-01	C162847	48780-1	3b156c62-2cf9-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR ® LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012
55292-139-01	2025-07-29	C162847	48780-1	3b156c62-2cf9-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use SIGNIFOR LAR safely and effectively. See full prescribing information for SIGNIFOR LAR. SIGNIFOR ® LAR (pasireotide) for injectable suspension, for intramuscular use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55292-134-01	Signifor LAR	6 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, FOR SUSPENSIO	6 mL	5 mg in 1mL	17
55292-139-01	Signifor LAR	1 in 1 KIT	KIT	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55292-139-01	EA - Each	55292-139	deb94343-2bef-4817-b681-c9352d761ddc	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55292-139	SIGNIFOR LAR (PASIREOTIDE) KIT [RECORDATI RARE DISEASES, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240719_a0aad470-3f38-af97-e053-2995a90a383a.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 · 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 ndc (product): 55292-139

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2049734	pasireotide LAR 10 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597596	pasireotide LAR 20 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
2049730	pasireotide LAR 30 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597601	pasireotide LAR 40 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597820	pasireotide LAR 60 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
2049736	Signifor LAR 10 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597599	Signifor LAR 20 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
2049732	Signifor LAR 30 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597603	Signifor LAR 40 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
1597822	Signifor LAR 60 MG Injection	PSN	a0aad470-3f38-af97-e053-2995a90a383a	17
2049736	pasireotide 10 MG Injection [Signifor]	SBD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597599	pasireotide 20 MG Injection [Signifor]	SBD	a0aad470-3f38-af97-e053-2995a90a383a	17
2049732	pasireotide 30 MG Injection [Signifor]	SBD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597603	pasireotide 40 MG Injection [Signifor]	SBD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597822	pasireotide 60 MG Injection [Signifor]	SBD	a0aad470-3f38-af97-e053-2995a90a383a	17
2049734	pasireotide 10 MG Injection	SCD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597596	pasireotide 20 MG Injection	SCD	a0aad470-3f38-af97-e053-2995a90a383a	17
2049730	pasireotide 30 MG Injection	SCD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597601	pasireotide 40 MG Injection	SCD	a0aad470-3f38-af97-e053-2995a90a383a	17
1597820	pasireotide 60 MG Injection	SCD	a0aad470-3f38-af97-e053-2995a90a383a	17
2049734	pasireotide LAR (as pasireotide pamoate) 10 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597596	pasireotide LAR (as pasireotide pamoate) 20 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
2049730	pasireotide LAR (as pasireotide pamoate) 30 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597601	pasireotide LAR (as pasireotide pamoate) 40 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597820	pasireotide LAR (as pasireotide pamoate) 60 mg Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
2049736	Signifor LAR (as pasireotide pamoate) 10 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597599	Signifor LAR (as pasireotide pamoate) 20 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
2049732	Signifor LAR (as pasireotide pamoate) 30 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597603	Signifor LAR (as pasireotide pamoate) 40 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17
1597822	Signifor LAR (as pasireotide pamoate) 60 MG Injection	SY	a0aad470-3f38-af97-e053-2995a90a383a	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55292-134-01	55292013401	6 mL in 1 VIAL, SINGLE-USE	6 ml					Historical
55292-139-01	55292013901	1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE	1 kit	2018-06-29	0000-00-00	No	No	Current