ABILIFY MAINTENA

Product NDC: 59148-045
11-digit product format: 591480045
Labeler code: 59148
Product ID: 59148-045_30e40a02-9942-4914-8d84-cf5a8058cec6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole
Dosage form: KIT
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA202971
Marketing category: NDA
Marketing start: 2014-10-08
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: ABILIFY MAINTENA
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1602163	Internal RxNorm lookup
1602171	Internal RxNorm lookup
1602604	Internal RxNorm lookup
1602607	Internal RxNorm lookup
1659812	Internal RxNorm lookup
1659814	Internal RxNorm lookup
1659816	Internal RxNorm lookup
1659818	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
915afeb5-0b22-42c0-86ea-77abf1c5fe15	Product name	1	20250307
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59148-045-80	ABILIFY MAINTENA	1 in 1 CARTON	KIT	1		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-045-80	EA - Each	59148-045	439a4dd9-8d8f-42cf-a041-b01d4348dd40	1	2015-02-02

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
59148-045	ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	26	Current NDC, Legacy NDC, 1 package rows	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 ndc (product): 59148-045

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
1659818	Abilify Maintena 300 MG Extended Release Injection	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	Abilify Maintena 300 MG Extended Release Prefilled Syringe	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659814	Abilify Maintena 400 MG Extended Release Injection	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	Abilify Maintena 400 MG Extended Release Prefilled Syringe	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659816	ARIPiprazole 300 MG Extended Release Injection	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602163	ARIPiprazole 300 MG Extended Release Prefilled Syringe	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659812	ARIPiprazole 400 MG Extended Release Injection	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602171	ARIPiprazole 400 MG in 2 ML Extended Release Prefilled Syringe	PSN	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	1.5 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify]	SBD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	2 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify]	SBD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659818	aripiprazole 300 MG Injection [Abilify]	SBD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659814	aripiprazole 400 MG Injection [Abilify]	SBD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602163	1.5 ML aripiprazole 200 MG/ML Prefilled Syringe	SCD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602171	2 ML aripiprazole 200 MG/ML Prefilled Syringe	SCD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659816	aripiprazole 300 MG Injection	SCD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659812	aripiprazole 400 MG Injection	SCD	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	1.5 ML Abilify 200 MG/ML Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	1.5 ML Abilify Maintena 200 MG/ML Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	2 ML Abilify 200 MG/ML Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	2 ML Abilify Maintena 200 MG/ML Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659818	Abilify 300 MG Injection	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659814	Abilify 400 MG Injection	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	Abilify Maintena 300 MG extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659818	Abilify Maintena 300 MG Injection	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602604	Abilify Maintena 300 MG per 1.5 ML extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	Abilify Maintena 400 MG extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1659814	Abilify Maintena 400 MG Injection	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602607	Abilify Maintena 400 MG per 2 ML extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602163	aripiprazole 300 MG extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602163	aripiprazole 300 MG per 1.5 ML extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602171	aripiprazole 400 MG extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27
1602171	aripiprazole 400 MG per 2 ML extended release Prefilled Syringe	SY	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-045-80	59148004580	1 KIT in 1 CARTON (59148-045-80) * 1.5 mL in 1 SYRINGE * 5 mL in 1 SYRINGE	1 kit	2014-10-08	0000-00-00	No	No	Current