Signifor

Product NDC: 0078-0633
Requested package NDC: 0078-0633-20
11-digit product format: 000780633
Labeler code: 0078
Product ID: 0078-0633_d345b840-7810-4bcf-9914-5444d1243a49
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pasireotide
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA200677
Marketing category: NDA
Marketing start: 2012-12-14
Marketing end: 2022-09-30
Substance: PASIREOTIDE
Active strength: 0 mg/mL
Pharmacologic classes: Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0633	0078-0633-20	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0633-06	ML - Milliliter	0078-0633	79bf7f08-6086-4155-9047-736d4a190868	1	2013-04-01
0078-0633-20	ML - Milliliter	0078-0633	1c7bb1e4-b3ce-4f87-896d-894020b69c40	1	2013-04-01
0078-0633-61	ML - Milliliter	0078-0633	f703418b-1268-4008-8e24-d8e2a537bd9c	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PASIREOTIDE	ACTIVE INGREDIENT	98H1T17066	SIGNIFOR (PASIREOTIDE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	2
PASIREOTIDE	ACTIVE MOIETY	98H1T17066	SIGNIFOR (PASIREOTIDE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	SIGNIFOR (PASIREOTIDE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SIGNIFOR (PASIREOTIDE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	2
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	SIGNIFOR (PASIREOTIDE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SIGNIFOR (PASIREOTIDE) INJECTION [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	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

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
0078-0633-20	00078063320	60 PACKAGE in 1 BOX (0078-0633-20) > 6 AMPULE in 1 PACKAGE (0078-0633-06) > 1 mL in 1 AMPULE (0078-0633-61)	60 package	2012-12-14	2022-09-30	No	No	Current