SAPHRIS

Product NDC: 0456-2405
11-digit product format: 004562405
Labeler code: 0456
Product ID: 0456-2405_9827c4dd-ffac-4022-a021-d1b15a364ecd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Asenapine Maleate
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Allergan, Inc.
Application: NDA022117
Marketing category: NDA
Marketing start: 2013-09-30
Substance: ASENAPINE MALEATE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0456-2405	0456-2405-63	D	Discontinued by firm		2026-08-03

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0456-2405-63	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0456-2405-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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	TE codes	RLD / RS	Approval date
N022117-001	SAPHRIS	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13
N022117-002	SAPHRIS	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13
N022117-003	SAPHRIS	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022117-001	AB
N022117-002	AB
N022117-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10
N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29
N022117-001	7741358*PED	2026-10-06		Pediatric extension
N022117-001	8022228*PED	2026-10-06		Pediatric extension
N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10
N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29
N022117-002	7741358*PED	2026-10-06		Pediatric extension
N022117-002	8022228*PED	2026-10-06		Pediatric extension
N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12
N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12
N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12
N022117-003	7741358*PED	2026-10-06		Pediatric extension
N022117-003	8022228*PED	2026-10-06		Pediatric extension

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022117-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022117-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022117-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022117-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 951 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	7741358*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	8022228*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	7741358*PED	2026-10-06		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`31067a03dcf5…`

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	N022117-001	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-001	I-597	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-002	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-002	I-597	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-003	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-003	I-597	2020-01-13	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022117-001	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-001	I-597	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-002	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-002	I-597	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-003	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-003	I-597	2020-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022117-001	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-001	I-597	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-002	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-002	I-597	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-003	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-003	I-597	2020-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022117-001	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-001	I-597	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-002	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-002	I-597	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-003	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-003	I-597	2020-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022117-001	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-001	I-597	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-002	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-002	I-597	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-003	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-003	I-597	2020-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022117-001	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-001	I-597	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-002	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-002	I-597	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-003	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-003	I-597	2020-01-13	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASENAPINE MALEATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CU9463U2E2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859975	Internal RxNorm lookup
859979	Internal RxNorm lookup
859981	Internal RxNorm lookup
859983	Internal RxNorm lookup
1606337	Internal RxNorm lookup
1606490	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
5429f134-839f-4ffc-9944-55f51238def8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5230498f-5ba0-2e92-5ec3-564c02237e72	Product name	3	20210607
e1a56ed3-15d0-4970-9174-95c3bde43653	Product name	1	20200309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0456-2405-06	SAPHRIS	10 in 1 BLISTER PACK	TABLET	10	22
0456-2405-06	SAPHRIS	1 in 1 CASE	TABLET	1	22
0456-2405-10	SAPHRIS	1 in 1 CARTON	TABLET	1	22
0456-2405-10	SAPHRIS	1 in 1 CASE	TABLET	1	22
0456-2405-11	SAPHRIS	10 in 1 BLISTER PACK	TABLET	10	22
0456-2405-60	SAPHRIS	6 in 1 CARTON	TABLET	6	22
0456-2405-63	SAPHRIS	10 in 1 CARTON	TABLET	10	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-2405-06	EA - Each	0456-2405	ca37fe3b-3b92-4813-a6e6-333c4fd8ee22	1	2017-04-05
0456-2405-11	EA - Each	0456-2405	e22586c7-bb50-4cae-89c1-a19894aee1c9	1	2016-07-19
0456-2405-60	EA - Each	0456-2405	858617af-87df-4312-96a0-b23a054ec61a	1	2014-11-05
0456-2405-63	EA - Each	0456-2405	0f101324-5b35-4335-a07c-65c877df324e	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Asenapine Maleate	ACTIVE INGREDIENT	CU9463U2E2	SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]	5
Asenapine	ACTIVE MOIETY	JKZ19V908O	SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]	5
gelatin	INACTIVE INGREDIENT	2G86QN327L	SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]	5
mannitol	INACTIVE INGREDIENT	3OWL53L36A	SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-2405	SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.]	21	Current NDC, Legacy NDC, 7 package rows	20250212_5429f134-839f-4ffc-9944-55f51238def8.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
SAPHRIS	ASENAPINE MALEATE	Allergan, Inc.	5429f134-839f-4ffc-9944-55f51238def8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022117 application number: NDA022117 ndc (product): 0456-2405

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CU9463U2E2	ASENAPINE MALEATE	85650-56-2	ASENAPINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859975	asenapine 10 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
1606337	asenapine 2.5 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
859981	asenapine 5 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
859979	Saphris 10 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
1606490	Saphris 2.5 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
859983	Saphris 5 MG Sublingual Tablet	PSN	5429f134-839f-4ffc-9944-55f51238def8	22
859979	asenapine 10 MG Sublingual Tablet [Saphris]	SBD	5429f134-839f-4ffc-9944-55f51238def8	22
1606490	asenapine 2.5 MG Sublingual Tablet [Saphris]	SBD	5429f134-839f-4ffc-9944-55f51238def8	22
859983	asenapine 5 MG Sublingual Tablet [Saphris]	SBD	5429f134-839f-4ffc-9944-55f51238def8	22
859975	asenapine 10 MG Sublingual Tablet	SCD	5429f134-839f-4ffc-9944-55f51238def8	22
1606337	asenapine 2.5 MG Sublingual Tablet	SCD	5429f134-839f-4ffc-9944-55f51238def8	22
859981	asenapine 5 MG Sublingual Tablet	SCD	5429f134-839f-4ffc-9944-55f51238def8	22
859975	asenapine (as asenapine maleate) 10 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
1606337	asenapine (as asenapine maleate) 2.5 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
859981	asenapine (as asenapine maleate) 5 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
859979	Saphris 10 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
1606490	Saphris 2.5 MG (as asenapine maleate) Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
1606490	Saphris 2.5 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22
859983	Saphris 5 MG Sublingual Tablet	SY	5429f134-839f-4ffc-9944-55f51238def8	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-2405-06	00456240506	10 in 1 BLISTER PACK						Historical
0456-2405-10	00456240510	1 CASE in 1 CARTON (0456-2405-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK	1 case	2013-09-30	0000-00-00	Yes	No	Current
0456-2405-11	00456240511	10 in 1 BLISTER PACK						Historical
0456-2405-60	00456240560	6 CASE in 1 CARTON (0456-2405-60) / 1 BLISTER PACK in 1 CASE (0456-2405-06) / 10 TABLET in 1 BLISTER PACK	6 case	2013-09-30	0000-00-00	No	No	Current
0456-2405-63	00456240563	10 BLISTER PACK in 1 CARTON (0456-2405-63) > 10 TABLET in 1 BLISTER PACK (0456-2405-11)	10 blister pack	2013-09-30	2022-01-31	No	No	Current