Signifor

Product NDC: 55292-131
11-digit product format: 552920131
Labeler code: 55292
Product ID: 55292-131_19a67a21-b599-41d1-9a7c-a5d31972d885
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pasireotide
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Recordati Rare Diseases, Inc.
Application: NDA200677
Marketing category: NDA
Marketing start: 2012-12-14
Substance: PASIREOTIDE
Active strength: .3 mg/mL
Pharmacologic classes: Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N200677-001	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14
N200677-002	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14
N200677-003	SIGNIFOR	PASIREOTIDE DIASPARTATE	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10
N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10
N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10

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 4 · 123 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	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-002	SIGNIFOR	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200677-003	SIGNIFOR	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200677-001	SIGNIFOR	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2012-12-14	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 240 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	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-001	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	8299209	2025-12-27	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-002	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	8299209	2025-12-27	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200677-003	7473761	2026-12-14	Drug substance, Drug product	2013-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200677-001	8299209	2025-12-27	Drug substance, Drug product	2013-01-10	`5bbf6a4d5a75…`

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	N200677-001	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200677-002	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200677-003	ODE-34	2019-12-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N200677-001	ODE-34	2019-12-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200677-002	ODE-34	2019-12-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200677-003	ODE-34	2019-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200677-001	ODE-34	2019-12-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200677-002	ODE-34	2019-12-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200677-003	ODE-34	2019-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200677-001	ODE-34	2019-12-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200677-002	ODE-34	2019-12-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200677-003	ODE-34	2019-12-14	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Signifor
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PASIREOTIDE	.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98H1T17066	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1364109	Internal RxNorm lookup
1364114	Internal RxNorm lookup
1364116	Internal RxNorm lookup
1364118	Internal RxNorm lookup
1364120	Internal RxNorm lookup
1364122	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
a09a25fc-a5a3-0c82-e053-2995a90a5d74	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
093f5f72-95bf-45e6-8f9d-fb29c1364d06	Product name	2	20180817

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55292-131-01	Signifor	1 mL in 1 AMPULE	INJECTION	1	20
55292-131-06	Signifor	6 in 1 PACKAGE	INJECTION	6	20
55292-131-60	Signifor	60 in 1 BOX	INJECTION	60	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55292-131-60	ML - Milliliter	55292-131	3280d645-0e59-4e6b-9114-e9984573a61f	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55292-131	SIGNIFOR (PASIREOTIDE) INJECTION [RECORDATI RARE DISEASES, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20250412_a09a25fc-a5a3-0c82-e053-2995a90a5d74.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	PASIREOTIDE	Recordati Rare Diseases, Inc.	a09a25fc-a5a3-0c82-e053-2995a90a5d74	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200677 application number: NDA200677 ndc (product): 55292-131

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
1364109	pasireotide 0.3 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364116	pasireotide 0.6 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364120	pasireotide 0.9 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364114	Signifor 0.3 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364118	Signifor 0.6 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364122	Signifor 0.9 MG in 1 ML Injection	PSN	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364114	1 ML pasireotide 0.3 MG/ML Injection [Signifor]	SBD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364118	1 ML pasireotide 0.6 MG/ML Injection [Signifor]	SBD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364122	1 ML pasireotide 0.9 MG/ML Injection [Signifor]	SBD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364109	1 ML pasireotide 0.3 MG/ML Injection	SCD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364116	1 ML pasireotide 0.6 MG/ML Injection	SCD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364120	1 ML pasireotide 0.9 MG/ML Injection	SCD	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364109	pasireotide (as pasireotide diaspartate) 0.3 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364116	pasireotide (as pasireotide diaspartate) 0.6 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364120	pasireotide (as pasireotide diaspartate) 0.9 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364109	pasireotide 0.3 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364116	pasireotide 0.6 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364120	pasireotide 0.9 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364114	Signifor (as pasireotide diaspartate) 0.3 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364118	Signifor (as pasireotide diaspartate) 0.6 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364122	Signifor (as pasireotide diaspartate) 0.9 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364114	Signifor 0.3 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364118	Signifor 0.6 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20
1364122	Signifor 0.9 MG per 1 ML Injection	SY	a09a25fc-a5a3-0c82-e053-2995a90a5d74	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55292-131-01	55292013101	1 mL in 1 AMPULE	1 ml					Historical
55292-131-06	55292013106	6 in 1 PACKAGE						Historical
55292-131-60	55292013160	60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01)	60 package	2012-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signifor	Recordati Rare Diseases, Inc. \| Delpharm DIjon \| Sterling Pharma Ringaskiddy LIMITED	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	20