SAPHRIS

Product NDC: 0052-2139
11-digit product format: 000522139
Labeler code: 0052
Product ID: 0052-2139_da55e2fe-c473-46cc-a4b4-d31c8e63d148
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Asenapine Maleate
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Organon Pharmaceuticals USA
Application: NDA022117
Marketing category: NDA
Marketing start: 2010-06-21
Marketing end: 0000-00-00
Substance: ASENAPINE MALEATE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0052-2139		D	Discontinued by firm	2026-10-20
excluded package	package	0052-2139	0052-2139-02	D	Discontinued by firm	2026-10-20
excluded package	package	0052-2139	0052-2139-03	D	Discontinued by firm	2026-10-20
excluded package	package	0052-2139	0052-2139-04	D	Discontinued by firm	2026-10-20

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 2 · 68 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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-2139-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-2139-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-2139-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-2139-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-2139-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-2139-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-2139-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-2139-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-2139-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-2139-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-2139-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-2139-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-2139-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-2139-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-2139-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-2139-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-2139-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-2139-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-2139-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-2139-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-2139-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-2139-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-2139-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-2139-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-2139-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-2139-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-2139-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-2139-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-2139-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-2139-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-2139-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-2139-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-2139-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-2139-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-2139-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-2139-03	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0052-2139-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0052-2139-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0052-2139-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0052-2139-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0052-2139-04	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0052-2139-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0052-2139-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0052-2139-04	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0052-2139-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022117-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022117-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022117-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022117-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022117-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022117-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022117-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 4 of 26 · 1,014 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	7741358*PED	2026-10-06		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	8022228*PED	2026-10-06		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	7741358*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	7741358*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	8022228*PED	2026-10-06		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`b8a1b40f171c…`

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0052-2139-02	2022-04-06	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009
0052-2139-03	2022-04-06	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009
0052-2139-04	2022-04-06	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009
0052-2139-02	2020-01-31	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009
0052-2139-03	2020-01-31	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009
0052-2139-04	2020-01-31	These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS ® (asenapine) sublingual tablets Initial U.S. Approval: 2009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0052-2139-03	EA - Each	0052-2139	c219eed5-e59a-4197-8b85-4aabba89fefb	1	2012-07-24
0052-2139-04	EA - Each	0052-2139	bfa15055-893e-4f09-90bc-360e7245fb8a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Asenapine Maleate	ACTIVE INGREDIENT	CU9463U2E2	SAPHRIS (ASENAPINE MALEATE) TABLET [ORGANON PHARMACEUTICALS USA]	16
Asenapine	ACTIVE MOIETY	JKZ19V908O	SAPHRIS (ASENAPINE MALEATE) TABLET [ORGANON PHARMACEUTICALS USA]	16
gelatin	INACTIVE INGREDIENT	2G86QN327L	SAPHRIS (ASENAPINE MALEATE) TABLET [ORGANON PHARMACEUTICALS USA]	16
mannitol	INACTIVE INGREDIENT	3OWL53L36A	SAPHRIS (ASENAPINE MALEATE) TABLET [ORGANON PHARMACEUTICALS USA]	16
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	SAPHRIS (ASENAPINE MALEATE) TABLET [ORGANON PHARMACEUTICALS USA]	16

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SAPHRIS	Organon Pharmaceuticals USA \| Catalent Pharma Solutions Limited \| N.V. Organon \| Organon (Ireland) Limited	2013-03-12	HUMAN PRESCRIPTION DRUG LABEL	16