ABILIFY

Product NDC: 43353-850
11-digit product format: 433530850
Labeler code: 43353
Product ID: 43353-850_bd5ca3e8-e294-46b9-94b4-3a66309a40b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARIPIPRAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021436
Marketing category: NDA
Marketing start: 2002-11-15
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 30 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-850		I	Inactivated by FDA	2026-10-05
excluded package	package	43353-850	43353-850-15	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-850	43353-850-18	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-850	43353-850-45	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-850	43353-850-99	I	Inactivated by FDA	2026-10-05

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 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-850-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-850-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-850-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-850-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-850-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-850-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-850-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-850-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-850-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-850-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-850-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-850-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-850-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-850-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-850-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-850-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-850-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-850-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-850-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-850-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-850-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-850-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-850-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-850-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-850-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-850-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-850-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-850-99	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-850-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-850-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-850-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-850-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-850-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-850-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-850-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-850-99	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-850-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-850-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-850-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-850-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-850-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-850-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-850-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-850-99	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-850-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-850-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-850-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-850-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021436-001	ABILIFY	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15
N021436-002	ABILIFY	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-003	ABILIFY	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-004	ABILIFY	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-005	ABILIFY	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-006	ABILIFY	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	RLD	2002-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021436-001	AB
N021436-002	AB
N021436-003	AB
N021436-004	AB
N021436-005	AB
N021436-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021436-001	9125939	2026-07-28	U-1749	2015-10-07
N021436-001	8759350	2027-03-02	U-1529	2014-07-22
N021436-002	9125939	2026-07-28	U-1749	2015-10-07
N021436-002	8759350	2027-03-02	U-1529	2014-07-22
N021436-003	9125939	2026-07-28	U-1749	2015-10-07
N021436-003	8759350	2027-03-02	U-1529	2014-07-22
N021436-004	9125939	2026-07-28	U-1749	2015-10-07
N021436-004	8759350	2027-03-02	U-1529	2014-07-22
N021436-005	9125939	2026-07-28	U-1749	2015-10-07
N021436-005	8759350	2027-03-02	U-1529	2014-07-22
N021436-006	9125939	2026-07-28	U-1749	2015-10-07
N021436-006	8759350	2027-03-02	U-1529	2014-07-22

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 7 · 258 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
2026-09-14 22:38:34	2026-08	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021436-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021436-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-004	AB	1	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 54 · 2,124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021436-001	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-002	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-003	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-004	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-005	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-006	ODE-80	2021-12-12	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021436-001	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-002	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-003	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-004	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-005	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-006	ODE-80	2021-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-001	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-002	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-003	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-004	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-005	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-006	ODE-80	2021-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021436-001	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-002	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-003	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-004	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-005	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-006	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021436-001	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-002	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-003	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-004	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-005	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-006	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021436-001	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-002	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-003	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-004	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-005	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-006	ODE-80	2021-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021436-001	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-002	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-003	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-004	ODE-80	2021-12-12	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
915afeb5-0b22-42c0-86ea-77abf1c5fe15	Product name	1	20250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6e	Product name	1	20231010
34645f32-2ac4-41bf-9c61-8107e4764a26	Product name	1	20181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d	Product name	1	20180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02	Product name	1	20170824
8223ef47-de85-24dd-a9c7-5a041d2634a2	Product name	9	20170223

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-850-15	These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002
43353-850-18	These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002
43353-850-45	These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002
43353-850-99	These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-850-15	ABILIFY	15 in 1 BOTTLE, PLASTIC	TABLET	15	1
43353-850-18	ABILIFY	3000 in 1 BOTTLE, PLASTIC	TABLET	3000	1
43353-850-45	ABILIFY	45 in 1 BOTTLE, PLASTIC	TABLET	45	1
43353-850-99	ABILIFY	600 in 1 BOTTLE, PLASTIC	TABLET	600	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-850-15	EA - Each	43353-850	78e4ff8c-84ce-4a2b-aefb-d875d5c9d0c6	1	2014-07-02
43353-850-18	EA - Each	43353-850	8acf37a2-1d13-49ad-b787-d1d411ac1013	1	2014-05-02
43353-850-45	EA - Each	43353-850	91bcf186-febd-48c4-a0d5-e1c0d8ae726f	1	2014-07-02
43353-850-99	EA - Each	43353-850	b2f08ec5-8bb6-40e3-9dcb-c365432ca3b7	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARIPIPRAZOLE	ACTIVE INGREDIENT	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ARIPIPRAZOLE	ACTIVE MOIETY	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-850	ABILIFY (ARIPIPRAZOLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 4 package rows	20140416_cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c.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
ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	c040bd1d-45b7-49f2-93ea-aed7220b30ac	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021436 application number: NDA021436

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82VFR53I78	ARIPIPRAZOLE	129722-12-9	ARIPIPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
352307	ABILIFY 10 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352309	ABILIFY 20 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352310	ABILIFY 30 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349545	ARIPiprazole 10 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349553	ARIPiprazole 20 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349547	ARIPiprazole 30 MG Oral Tablet	PSN	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352307	aripiprazole 10 MG Oral Tablet [Abilify]	SBD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352309	aripiprazole 20 MG Oral Tablet [Abilify]	SBD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352310	aripiprazole 30 MG Oral Tablet [Abilify]	SBD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349545	aripiprazole 10 MG Oral Tablet	SCD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349553	aripiprazole 20 MG Oral Tablet	SCD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
349547	aripiprazole 30 MG Oral Tablet	SCD	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352307	Abilify 10 MG Oral Tablet	SY	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352309	Abilify 20 MG Oral Tablet	SY	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1
352310	Abilify 30 MG Oral Tablet	SY	cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-850-15	43353085015	15 in 1 BOTTLE, PLASTIC	Historical
43353-850-18	43353085018	3000 in 1 BOTTLE, PLASTIC	Historical
43353-850-45	43353085045	45 in 1 BOTTLE, PLASTIC	Historical
43353-850-99	43353085099	600 in 1 BOTTLE, PLASTIC	Historical