ARISTADA

Product NDC: 65757-404
11-digit product format: 657570404
Labeler code: 65757
Product ID: 65757-404_3d951a36-1e73-4f84-8ebf-4d556d81a086
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole lauroxil
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Alkermes, Inc.
Application: NDA207533
Marketing category: NDA
Marketing start: 2017-06-05
Substance: ARIPIPRAZOLE LAUROXIL
Active strength: 1064 mg/3.9mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65757-404		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	65757-404	65757-404-00	UNFINISHED	Active or certified unfinished drug listing		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 · 30 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65757-404-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65757-404-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65757-404-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65757-404-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65757-404-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65757-404-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65757-404-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65757-404-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65757-404-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65757-404-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65757-404-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65757-404-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65757-404-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65757-404-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65757-404-00	`906f6e251498…`	`bf70b80e44f0…`

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

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
N207533-001	ARISTADA	ARIPIPRAZOLE LAUROXIL	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05
N207533-002	ARISTADA	ARIPIPRAZOLE LAUROXIL	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05
N207533-003	ARISTADA	ARIPIPRAZOLE LAUROXIL	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05
N207533-004	ARISTADA	ARIPIPRAZOLE LAUROXIL	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05

Orange Book patents#

Current patent rows page 1 of 1 · 70 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207533-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-001	8796276	2030-06-24	U-543		2015-10-14
N207533-001	8431576	2030-10-26		Drug substance	2015-10-14
N207533-001	10226458	2032-03-19	U-543		2019-04-08
N207533-001	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-001	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-001	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-001	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-001	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-001	11969469	2034-04-06		Drug product	2024-05-16
N207533-001	10238651	2035-03-19	U-2402		2019-04-08
N207533-001	10813928	2035-03-19	U-2983		2020-11-10
N207533-001	11406632	2035-03-19	U-2402		2022-08-19
N207533-001	12653822	2035-03-19	U-2402		2026-07-15
N207533-001	9452131	2035-03-19	U-2402		2016-10-05
N207533-001	11273158	2039-04-06	U-543		2022-04-13
N207533-001	12251381	2039-04-06	U-543		2025-04-08
N207533-002	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-002	8796276	2030-06-24	U-543		2015-10-14
N207533-002	8431576	2030-10-26		Drug substance	2015-10-14
N207533-002	10226458	2032-03-19	U-543		2019-04-08
N207533-002	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-002	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-002	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-002	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-002	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-002	11969469	2034-04-06		Drug product	2024-05-16
N207533-002	10238651	2035-03-19	U-2402		2019-04-08
N207533-002	10813928	2035-03-19	U-2983		2020-11-10
N207533-002	11406632	2035-03-19	U-2402		2022-08-19
N207533-002	12653822	2035-03-19	U-2402		2026-07-15
N207533-002	9452131	2035-03-19	U-2402		2016-10-05
N207533-002	9526726	2035-03-19		Drug product	2017-01-19
N207533-002	11273158	2039-04-06	U-543		2022-04-13
N207533-002	12251381	2039-04-06	U-543		2025-04-08
N207533-003	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-003	8796276	2030-06-24	U-543		2015-10-14
N207533-003	8431576	2030-10-26		Drug substance	2015-10-14
N207533-003	10226458	2032-03-19	U-543		2019-04-08
N207533-003	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-003	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-003	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-003	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-003	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-003	11969469	2034-04-06		Drug product	2024-05-16
N207533-003	10238651	2035-03-19	U-2402		2019-04-08
N207533-003	10813928	2035-03-19	U-2402		2020-11-10
N207533-003	11406632	2035-03-19	U-2402		2022-08-19
N207533-003	12653822	2035-03-19	U-2402		2026-07-15
N207533-003	9452131	2035-03-19	U-2402		2016-10-05
N207533-003	9526726	2035-03-19		Drug product	2017-01-19
N207533-003	11273158	2039-04-06	U-543		2022-04-13
N207533-003	12251381	2039-04-06	U-543		2025-04-08
N207533-004	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-004	8796276	2030-06-24	U-543		2017-06-27
N207533-004	8431576	2030-10-26		Drug substance	2017-06-27
N207533-004	10226458	2032-03-19	U-543		2019-04-08
N207533-004	9034867	2032-11-07	U-543	Drug product	2017-06-27
N207533-004	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-004	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-004	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-004	9193685	2033-10-24	U-543	Drug product	2017-06-27
N207533-004	11969469	2034-04-06		Drug product	2024-05-16
N207533-004	10238651	2035-03-19	U-2402		2019-04-08
N207533-004	10813928	2035-03-19	U-2983		2020-11-10
N207533-004	11406632	2035-03-19	U-2402		2022-08-19
N207533-004	12653822	2035-03-19	U-2402		2026-07-15
N207533-004	9452131	2035-03-19	U-2402		2017-06-27
N207533-004	11273158	2039-04-06	U-543		2022-04-13
N207533-004	12251381	2039-04-06	U-543		2025-04-08

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 · 168 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	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 51 · 2,016 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207533-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12629366	2032-12-06	U-764	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11097006	2033-09-19	U-764	Drug product	2021-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12311027	2033-09-19	U-543	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9193685	2033-10-24	U-543	Drug product	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11969469	2034-04-06		Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10238651	2035-03-19	U-2402		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10813928	2035-03-19	U-2983		2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11406632	2035-03-19	U-2402		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12653822	2035-03-19	U-2402		2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9452131	2035-03-19	U-2402		2016-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12629366	2032-12-06	U-764	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11097006	2033-09-19	U-764	Drug product	2021-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12311027	2033-09-19	U-543	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9193685	2033-10-24	U-543	Drug product	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11969469	2034-04-06		Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10238651	2035-03-19	U-2402		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10813928	2035-03-19	U-2983		2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11406632	2035-03-19	U-2402		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12653822	2035-03-19	U-2402		2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9452131	2035-03-19	U-2402		2016-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9526726	2035-03-19		Drug product	2017-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`

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	N207533-001	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-002	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-003	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-004	NCE	2020-10-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207533-001	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-002	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-003	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-004	NCE	2020-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207533-001	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-002	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-003	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-004	NCE	2020-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207533-001	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-002	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-003	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-004	NCE	2020-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207533-001	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-002	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-003	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-004	NCE	2020-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207533-001	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-002	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-003	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-004	NCE	2020-10-05	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: ARISTADA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE LAUROXIL	1064 mg/3.9mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B786J7A343	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1673269	Internal RxNorm lookup
1673274	Internal RxNorm lookup
1673277	Internal RxNorm lookup
1673278	Internal RxNorm lookup
1673279	Internal RxNorm lookup
1673280	Internal RxNorm lookup
1925262	Internal RxNorm lookup
1925264	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
17a8d11b-73b0-4833-a0b4-cf1ef85edefb	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
51c1e9bf-32c5-4a7b-b010-f93a90af7b6e	Product name	1	20231010
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
34645f32-2ac4-41bf-9c61-8107e4764a26	Product name	1	20181210
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d	Product name	1	20180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02	Product name	1	20170824
7af8ba3d-8c7a-4c9f-806c-a55cd50e39be	Product name	1	20170725
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
8223ef47-de85-24dd-a9c7-5a041d2634a2	Product name	9	20170223
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65757-404-03	ARISTADA	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	32
65757-404-03	ARISTADA	3.9 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	3.9	32
65757-404-04	ARISTADA	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	32
65757-404-04	ARISTADA	3.9 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	3.9	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65757-404-01	ML - Milliliter	65757-404	caacb56b-e6b6-4044-bd49-ac8b8957bf99	1	2017-07-07
65757-404-03	ML - Milliliter	65757-404	97432638-8f5f-4d58-9a0f-b5b81b2ef3e1	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
aripiprazole lauroxil	ACTIVE INGREDIENT	B786J7A343	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
aripiprazole lauroxil	ACTIVE MOIETY	B786J7A343	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Sodium Phosphate, Monobasic, Anhydrous	INACTIVE INGREDIENT	KH7I04HPUU	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Sorbitan Monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65757-404	ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	32	Current NDC, Legacy NDC, 4 package rows	20250210_17a8d11b-73b0-4833-a0b4-cf1ef85edefb.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
ARISTADA	ARIPIPRAZOLE LAUROXIL	Alkermes, Inc.	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207533 application number: NDA207533 ndc (product): 65757-404

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B786J7A343	ARIPIPRAZOLE LAUROXIL	1259305-29-7	ARIPIPRAZOLE LAUROXIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1925262	ARIPiprazole lauroxil 1064 MG in 3.9 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673269	ARIPiprazole lauroxil 441 MG in 1.6 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673277	ARIPiprazole lauroxil 662 MG in 2.4 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673279	ARIPiprazole lauroxil 882 MG in 3.2 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925264	Aristada 1064 MG in 3.9 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673274	Aristada 441 MG in 1.6 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673278	Aristada 662 MG in 2.4 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673280	Aristada 882 MG in 3.2 ML Prefilled Syringe	PSN	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673274	1.6 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]	SBD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673278	2.4 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]	SBD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673280	3.2 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe [Aristada]	SBD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925264	3.9 ML aripiprazole lauroxil 273 MG/ML Prefilled Syringe [Aristada]	SBD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673269	1.6 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe	SCD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673277	2.4 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe	SCD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673279	3.2 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe	SCD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925262	3.9 ML aripiprazole lauroxil 273 MG/ML Prefilled Syringe	SCD	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925264	3.9 ML Aristada 273 MG/ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925262	aripiprazole lauroxil 1064 MG per 3.9 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673277	aripiprazole lauroxil 276 MG/ML per 2.4 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673279	aripiprazole lauroxil 276 MG/ML per 3.2 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673269	aripiprazole lauroxil 441 MG per 1.6 ML Extended Release Suspension Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673269	aripiprazole lauroxil 441 MG per 1.6 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673277	aripiprazole lauroxil 662 MG per 2.4 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673279	aripiprazole lauroxil 882 MG per 3.2 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925264	Aristada 1064 MG per 3.9 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1925264	Aristada 273 MG/ML per 3.9 ML Prefilled	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673278	Aristada 276 MG/ML per 2.4 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673280	Aristada 276 MG/ML per 3.2 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673274	Aristada 441 MG per 1.6 ML Extended Release Suspension Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673274	Aristada 441 MG per 1.6 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673278	Aristada 662 MG per 2.4 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32
1673280	Aristada 882 MG per 3.2 ML Prefilled Syringe	SY	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65757-404-00	65757040400	20 TRAY in 1 CARTON (65757-404-00) / 15 SYRINGE in 1 TRAY / 3.9 mL in 1 SYRINGE	20 tray	05-JUN-17				Current
65757-404-03	65757040403	1 SYRINGE in 1 CARTON (65757-404-03) / 3.9 mL in 1 SYRINGE	1 syringe	2017-06-05	0000-00-00	No	No	Current
65757-404-04	65757040404	1 SYRINGE in 1 CARTON (65757-404-04) / 3.9 mL in 1 SYRINGE	1 syringe	2017-06-05	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARISTADA	Alkermes, Inc. \| Alkermes, Inc \| Sharp Corporation	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	32