ABILIFY MAINTENA

Product NDC: 59148-019
11-digit product format: 591480019
Labeler code: 59148
Product ID: 59148-019_1bb09ce4-c128-4f90-9258-6c579c7c0854
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole
Dosage form: KIT
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA202971
Marketing category: NDA
Marketing start: 2013-02-28
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59148-019		D	Discontinued by firm	2026-09-14
excluded package	package	59148-019	59148-019-71	D	Discontinued by firm	2026-09-14
excluded package	package	59148-019	59148-019-91	D	Discontinued by firm	2026-09-14

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N202971-001	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2013-02-28
N202971-002	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2013-02-28
N202971-003	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2014-09-29
N202971-004	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2014-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202971-001	10980803	2033-09-24	U-1632		2021-05-19
N202971-001	10980803	2033-09-24	U-543		2021-05-19
N202971-001	11154553	2033-09-24	U-1632		2021-11-17
N202971-001	11154553	2033-09-24	U-3245		2021-11-17
N202971-001	11154553	2033-09-24	U-814		2021-11-17
N202971-001	11344547	2033-09-24	U-1632		2022-06-24
N202971-001	11344547	2033-09-24	U-3245		2022-06-24
N202971-001	11344547	2033-09-24	U-814		2022-06-24
N202971-001	11400087	2033-09-24	U-1632		2022-08-29
N202971-001	11400087	2033-09-24	U-3245		2022-08-29
N202971-001	11400087	2033-09-24	U-814		2022-08-29
N202971-001	10525057	2034-03-08	U-1632		2020-01-31
N202971-001	10525057	2034-03-08	U-2723		2020-01-31
N202971-001	10525057	2034-03-08	U-543		2020-01-31
N202971-001	11648347	2034-04-06		Drug product	2023-06-15
N202971-001	12691056	2041-04-01	U-3245		2026-08-26
N202971-001	12691056	2041-04-01	U-814		2026-08-26
N202971-002	10980803	2033-09-24	U-1632		2021-05-19
N202971-002	10980803	2033-09-24	U-543		2021-05-19
N202971-002	11154553	2033-09-24	U-1632		2021-11-17
N202971-002	11154553	2033-09-24	U-3245		2021-11-17
N202971-002	11154553	2033-09-24	U-814		2021-11-17
N202971-002	11344547	2033-09-24	U-1632		2022-06-24
N202971-002	11344547	2033-09-24	U-3245		2022-06-24
N202971-002	11344547	2033-09-24	U-814		2022-06-24
N202971-002	11400087	2033-09-24	U-1632		2022-08-29
N202971-002	11400087	2033-09-24	U-3245		2022-08-29
N202971-002	11400087	2033-09-24	U-814		2022-08-29
N202971-002	10525057	2034-03-08	U-1632		2020-01-31
N202971-002	10525057	2034-03-08	U-2723		2020-01-31
N202971-002	10525057	2034-03-08	U-543		2020-01-31
N202971-002	11648347	2034-04-06		Drug product	2023-06-15
N202971-002	12691056	2041-04-01	U-3245		2026-08-26
N202971-002	12691056	2041-04-01	U-814		2026-08-26
N202971-003	10980803	2033-09-24	U-1632		2021-05-19
N202971-003	10980803	2033-09-24	U-543		2021-05-19
N202971-003	11154553	2033-09-24	U-1632		2021-11-17
N202971-003	11154553	2033-09-24	U-3245		2021-11-17
N202971-003	11154553	2033-09-24	U-814		2021-11-17
N202971-003	11344547	2033-09-24	U-1632		2022-06-24
N202971-003	11344547	2033-09-24	U-3245		2022-06-24
N202971-003	11344547	2033-09-24	U-814		2022-06-24
N202971-003	11400087	2033-09-24	U-1632		2022-08-29
N202971-003	11400087	2033-09-24	U-3245		2022-08-29
N202971-003	11400087	2033-09-24	U-814		2022-08-29
N202971-003	10525057	2034-03-08	U-1632		2020-01-31
N202971-003	10525057	2034-03-08	U-2723		2020-01-31
N202971-003	10525057	2034-03-08	U-543		2020-01-31
N202971-003	11648347	2034-04-06		Drug product	2023-06-15
N202971-003	12691056	2041-04-01	U-3245		2026-08-26
N202971-003	12691056	2041-04-01	U-814		2026-08-26
N202971-004	10980803	2033-09-24	U-1632		2021-05-19
N202971-004	10980803	2033-09-24	U-543		2021-05-19
N202971-004	11154553	2033-09-24	U-1632		2021-11-17
N202971-004	11154553	2033-09-24	U-3245		2021-11-17
N202971-004	11154553	2033-09-24	U-814		2021-11-17
N202971-004	11344547	2033-09-24	U-1632		2022-06-24
N202971-004	11344547	2033-09-24	U-3245		2022-06-24
N202971-004	11344547	2033-09-24	U-814		2022-06-24
N202971-004	11400087	2033-09-24	U-1632		2022-08-29
N202971-004	11400087	2033-09-24	U-3245		2022-08-29
N202971-004	11400087	2033-09-24	U-814		2022-08-29
N202971-004	10525057	2034-03-08	U-1632		2020-01-31
N202971-004	10525057	2034-03-08	U-2723		2020-01-31
N202971-004	10525057	2034-03-08	U-543		2020-01-31
N202971-004	11648347	2034-04-06		Drug product	2023-06-15
N202971-004	12691056	2041-04-01	U-3245		2026-08-26
N202971-004	12691056	2041-04-01	U-814		2026-08-26

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 5 · 172 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	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD	2013-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2013-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD	2013-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2013-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-002	AP	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 89 · 3,528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202971-001	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-3245		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-814		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-3245		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-814		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-1632		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-543		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-1632		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-2723		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11648347	2034-04-06		Drug product	2023-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	12691056	2041-04-01	U-814		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	12691056	2041-04-01	U-3245		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-3245		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-814		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-814		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-3245		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-1632		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-2723		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-1632		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-543		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11648347	2034-04-06		Drug product	2023-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	12691056	2041-04-01	U-814		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	12691056	2041-04-01	U-3245		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`

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	N202971-001	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-002	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-003	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-004	I-746	2020-07-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202971-001	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-002	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-003	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-004	I-746	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202971-001	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-002	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-003	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-004	I-746	2020-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202971-001	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-002	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-003	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-004	I-746	2020-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202971-001	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-002	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-003	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-004	I-746	2020-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202971-001	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-002	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-003	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-004	I-746	2020-07-27	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-019-71	EA - Each	59148-019	e7acb5ea-f257-4022-9808-8b343911bcad	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
aripiprazole	ACTIVE INGREDIENT	82VFR53I78	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
aripiprazole	ACTIVE MOIETY	82VFR53I78	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
mannitol	INACTIVE INGREDIENT	3OWL53L36A	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
sodium phosphate, monobasic, monohydrate	INACTIVE INGREDIENT	593YOG76RN	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9
Water	INACTIVE INGREDIENT	059QF0KO0R	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-019	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	26	Legacy NDC	20250417_ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6.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 MAINTENA	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202971 application number: NDA202971

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-019-71	59148001971	1 KIT in 1 CARTON (59148-019-71) * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE	1 kit	2013-02-28	0000-00-00	No	No	Current