Fanapt

Product NDC: 69189-0665
11-digit product format: 691890665
Labeler code: 69189
Product ID: 69189-0665_9cfe65cc-b53f-4931-b5ed-ad695227ee97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: iloperidone
Dosage form: TABLET
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA022192
Marketing category: NDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: ILOPERIDONE
Active strength: 4 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69189-0665		I	Inactivated by FDA		2026-08-17
excluded package	package	69189-0665	69189-0665-1	I	Inactivated by FDA		2026-08-17

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69189-0665-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69189-0665-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69189-0665-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-0665-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-0665-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-0665-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-0665-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-0665-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-0665-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-0665-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-0665-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-0665-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-0665-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-0665-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-0665-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-0665-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-0665-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
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	69189-0665-1	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	69189-0665-1	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	69189-0665-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-0665-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-0665-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022192-001	FANAPT	ILOPERIDONE	1MG	TABLET / ORAL	RLD, RS	2009-05-06
N022192-002	FANAPT	ILOPERIDONE	2MG	TABLET / ORAL	RLD	2009-05-06
N022192-003	FANAPT	ILOPERIDONE	4MG	TABLET / ORAL	RLD	2009-05-06
N022192-004	FANAPT	ILOPERIDONE	6MG	TABLET / ORAL	RLD	2009-05-06
N022192-005	FANAPT	ILOPERIDONE	8MG	TABLET / ORAL	RLD	2009-05-06
N022192-006	FANAPT	ILOPERIDONE	10MG	TABLET / ORAL	RLD	2009-05-06
N022192-007	FANAPT	ILOPERIDONE	12MG	TABLET / ORAL	RLD	2009-05-06

Orange Book patents#

Current patent rows page 1 of 2 · 98 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022192-001	8586610	2027-11-02	U-1625	2015-01-08
N022192-001	10570453	2028-03-28	U-4562	2026-07-09
N022192-001	10570453	2028-03-28	U-4563	2026-07-09
N022192-001	9157121	2030-04-05	U-1674	2015-10-13
N022192-001	10563259	2030-07-24	U-4562	2026-07-09
N022192-001	10563259	2030-07-24	U-4563	2026-07-09
N022192-001	8652776	2030-08-31	U-1685	2015-04-30
N022192-001	12606869	2030-09-22	U-4504	2026-05-21
N022192-001	12606869	2030-09-22	U-4505	2026-05-21
N022192-001	8999638	2030-10-28	U-1674	2015-04-07
N022192-001	9074255	2030-12-17	U-1674	2015-07-28
N022192-001	9072742	2031-01-16	U-1674	2015-07-28
N022192-001	9074256	2031-02-10	U-1674	2015-07-28
N022192-001	9074254	2031-12-28	U-1674	2015-07-28
N022192-002	8586610	2027-11-02	U-1625	2015-01-08
N022192-002	10570453	2028-03-28	U-4562	2026-07-09
N022192-002	10570453	2028-03-28	U-4563	2026-07-09
N022192-002	9157121	2030-04-05	U-1674	2015-10-13
N022192-002	10563259	2030-07-24	U-4562	2026-07-09
N022192-002	10563259	2030-07-24	U-4563	2026-07-09
N022192-002	8652776	2030-08-31	U-1685	2015-04-30
N022192-002	12606869	2030-09-22	U-4504	2026-05-21
N022192-002	12606869	2030-09-22	U-4505	2026-05-21
N022192-002	8999638	2030-10-28	U-1674	2015-04-07
N022192-002	9074255	2030-12-17	U-1674	2015-07-28
N022192-002	9072742	2031-01-16	U-1674	2015-07-28
N022192-002	9074256	2031-02-10	U-1674	2015-07-28
N022192-002	9074254	2031-12-28	U-1674	2015-07-28
N022192-003	8586610	2027-11-02	U-1625	2015-01-08
N022192-003	10570453	2028-03-28	U-4562	2026-07-09
N022192-003	10570453	2028-03-28	U-4563	2026-07-09
N022192-003	9157121	2030-04-05	U-1674	2015-10-13
N022192-003	10563259	2030-07-24	U-4562	2026-07-09
N022192-003	10563259	2030-07-24	U-4563	2026-07-09
N022192-003	8652776	2030-08-31	U-1685	2015-04-30
N022192-003	12606869	2030-09-22	U-4504	2026-05-21
N022192-003	12606869	2030-09-22	U-4505	2026-05-21
N022192-003	8999638	2030-10-28	U-1674	2015-04-07
N022192-003	9074255	2030-12-17	U-1674	2015-07-28
N022192-003	9072742	2031-01-16	U-1674	2015-07-28
N022192-003	9074256	2031-02-10	U-1674	2015-07-28
N022192-003	9074254	2031-12-28	U-1674	2015-07-28
N022192-004	8586610	2027-11-02	U-1625	2015-01-08
N022192-004	10570453	2028-03-28	U-4562	2026-07-09
N022192-004	10570453	2028-03-28	U-4563	2026-07-09
N022192-004	9157121	2030-04-05	U-1674	2015-10-13
N022192-004	10563259	2030-07-24	U-4562	2026-07-09
N022192-004	10563259	2030-07-24	U-4563	2026-07-09
N022192-004	8652776	2030-08-31	U-1685	2015-04-30
N022192-004	12606869	2030-09-22	U-4504	2026-05-21
N022192-004	12606869	2030-09-22	U-4505	2026-05-21
N022192-004	8999638	2030-10-28	U-1674	2015-04-07
N022192-004	9074255	2030-12-17	U-1674	2015-07-28
N022192-004	9072742	2031-01-16	U-1674	2015-07-28
N022192-004	9074256	2031-02-10	U-1674	2015-07-28
N022192-004	9074254	2031-12-28	U-1674	2015-07-28
N022192-005	8586610	2027-11-02	U-1625	2015-01-08
N022192-005	10570453	2028-03-28	U-4562	2026-07-09
N022192-005	10570453	2028-03-28	U-4563	2026-07-09
N022192-005	9157121	2030-04-05	U-1674	2015-10-13
N022192-005	10563259	2030-07-24	U-4562	2026-07-09
N022192-005	10563259	2030-07-24	U-4563	2026-07-09
N022192-005	8652776	2030-08-31	U-1685	2015-04-30
N022192-005	12606869	2030-09-22	U-4504	2026-05-21
N022192-005	12606869	2030-09-22	U-4505	2026-05-21
N022192-005	8999638	2030-10-28	U-1674	2015-04-07
N022192-005	9074255	2030-12-17	U-1674	2015-07-28
N022192-005	9072742	2031-01-16	U-1674	2015-07-28
N022192-005	9074256	2031-02-10	U-1674	2015-07-28
N022192-005	9074254	2031-12-28	U-1674	2015-07-28
N022192-006	8586610	2027-11-02	U-1625	2015-01-08
N022192-006	10570453	2028-03-28	U-4562	2026-07-09
N022192-006	10570453	2028-03-28	U-4563	2026-07-09
N022192-006	9157121	2030-04-05	U-1674	2015-10-13
N022192-006	10563259	2030-07-24	U-4562	2026-07-09
N022192-006	10563259	2030-07-24	U-4563	2026-07-09
N022192-006	8652776	2030-08-31	U-1685	2015-04-30
N022192-006	12606869	2030-09-22	U-4504	2026-05-21
N022192-006	12606869	2030-09-22	U-4505	2026-05-21
N022192-006	8999638	2030-10-28	U-1674	2015-04-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022192-001	I-939	2027-04-02
N022192-002	I-939	2027-04-02
N022192-003	I-939	2027-04-02
N022192-004	I-939	2027-04-02
N022192-005	I-939	2027-04-02
N022192-006	I-939	2027-04-02
N022192-007	I-939	2027-04-02

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 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-007	AB	1	`5c6f7cd8ea54…`
2019-07-19 19:46 UTC	2019-07	N022192-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-007	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-006	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-007	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 68 · 2,709 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022192-001	8586610	2027-11-02	U-1625	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	10570453	2028-03-28	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	10570453	2028-03-28	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	9157121	2030-04-05	U-1674	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	10563259	2030-07-24	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	10563259	2030-07-24	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	8652776	2030-08-31	U-1685	2015-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	12606869	2030-09-22	U-4504	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	12606869	2030-09-22	U-4505	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	8999638	2030-10-28	U-1674	2015-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	9074255	2030-12-17	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	9072742	2031-01-16	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	9074256	2031-02-10	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-001	9074254	2031-12-28	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	8586610	2027-11-02	U-1625	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	10570453	2028-03-28	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	10570453	2028-03-28	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	9157121	2030-04-05	U-1674	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	10563259	2030-07-24	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	10563259	2030-07-24	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	8652776	2030-08-31	U-1685	2015-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	12606869	2030-09-22	U-4504	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	12606869	2030-09-22	U-4505	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	8999638	2030-10-28	U-1674	2015-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	9074255	2030-12-17	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	9072742	2031-01-16	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	9074256	2031-02-10	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	9074254	2031-12-28	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	8586610	2027-11-02	U-1625	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	10570453	2028-03-28	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	10570453	2028-03-28	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	9157121	2030-04-05	U-1674	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	10563259	2030-07-24	U-4562	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	10563259	2030-07-24	U-4563	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	8652776	2030-08-31	U-1685	2015-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	12606869	2030-09-22	U-4504	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	12606869	2030-09-22	U-4505	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	8999638	2030-10-28	U-1674	2015-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	9074255	2030-12-17	U-1674	2015-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	9072742	2031-01-16	U-1674	2015-07-28	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N022192-001	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-002	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-003	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-004	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-005	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-006	I-939	2027-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022192-007	I-939	2027-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022192-001	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-006	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-007	I-939	2027-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-001	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-002	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-003	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-004	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-005	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-006	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-007	I-939	2027-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022192-001	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-002	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-003	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-004	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-005	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-006	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-007	I-939	2027-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-001	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-002	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-003	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-004	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-005	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-006	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-007	I-939	2027-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-001	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-002	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-003	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-004	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-005	I-939	2027-04-02	`b8a1b40f171c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c2441bbe-3ea0-4d2c-96a6-138bc08a4e8c	Product name	2	20170213

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-0665-1	2020-01-31	C162847	48780-1	9d75b9d0-836b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FANAPT safely and effectively. See full prescribing information for FANAPT. FANAPT ® (iloperidone) tablets Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-0665-1	Fanapt	1 in 1 DOSE PACK	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-0665	FANAPT (ILOPERIDONE) TABLET [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20170410_69d63a08-1920-427a-a967-2ffea04fd974.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
FANAPT	ILOPERIDONE	Vanda Pharmaceuticals Inc.	33f60b40-3fca-11de-8f56-0002a5d5c51b	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022192 application number: NDA022192

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VPO7KJ050N	ILOPERIDONE	133454-47-4	ILOPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848742	Fanapt 4 MG Oral Tablet	PSN	69d63a08-1920-427a-a967-2ffea04fd974	1
848740	iloperidone 4 MG Oral Tablet	PSN	69d63a08-1920-427a-a967-2ffea04fd974	1
848742	iloperidone 4 MG Oral Tablet [Fanapt]	SBD	69d63a08-1920-427a-a967-2ffea04fd974	1
848740	iloperidone 4 MG Oral Tablet	SCD	69d63a08-1920-427a-a967-2ffea04fd974	1
848742	Fanapt 4 MG Oral Tablet	SY	69d63a08-1920-427a-a967-2ffea04fd974	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-0665-1	69189066501	1 in 1 DOSE PACK	Historical