ARISTADA INITIO

Product NDC: 65757-500
11-digit product format: 657570500
Labeler code: 65757
Product ID: 65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole lauroxil
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Alkermes, Inc.
Application: NDA209830
Marketing category: NDA
Marketing start: 2018-06-29
Substance: ARIPIPRAZOLE LAUROXIL
Active strength: 675 mg/2.4mL
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	65757-500		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	65757-500	65757-500-00	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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`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	65757-500-00	`906f6e251498…`	`bf70b80e44f0…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209830-001	ARISTADA INITIO KIT	ARIPIPRAZOLE LAUROXIL	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2018-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N209830-001	8796276	2030-06-24	U-543		2018-07-18
N209830-001	8431576	2030-10-26		Drug substance	2018-07-18
N209830-001	10688091	2035-08-17		Drug product	2020-07-08
N209830-001	10849894	2035-08-17	U-543		2020-12-09
N209830-001	11154552	2035-08-17		Drug product	2021-11-10
N209830-001	10016415	2035-09-08		Drug product	2018-07-18
N209830-001	11273158	2039-04-06	U-543		2022-04-13
N209830-001	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 2 · 42 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	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 312 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	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`fd3edfee7708…`

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	N209830-001	NCE	2020-10-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209830-001	NCE	2020-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209830-001	NCE	2020-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209830-001	NCE	2020-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209830-001	NCE	2020-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209830-001	NCE	2020-10-05	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE LAUROXIL	675 mg/2.4mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2049341	Internal RxNorm lookup
2049343	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
b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	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
7af8ba3d-8c7a-4c9f-806c-a55cd50e39be	Product name	1	20170725
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	SPL version
65757-500-03	ARISTADA INITIO	2.4 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	2.4	16
65757-500-03	ARISTADA INITIO	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	16
65757-500-04	ARISTADA INITIO	2.4 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	2.4	16
65757-500-04	ARISTADA INITIO	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65757-500-03	ML - Milliliter	65757-500	2c96eec6-8459-4f31-b994-96cdd96e7f9f	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65757-500	ARISTADA INITIO (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]	16	Current NDC, Legacy NDC, 4 package rows	20250210_b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403.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 INITIO	ARIPIPRAZOLE LAUROXIL	Alkermes, Inc.	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209830 application number: NDA209830 ndc (product): 65757-500

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
2049341	ARIPiprazole lauroxil 675 MG in 2.4 ML Prefilled Syringe	PSN	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049343	Aristada Initio Starter Dose 675 MG in 2.4 ML Prefilled Syringe	PSN	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049343	2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]	SBD	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049341	2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe	SCD	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049343	2.4 ML Aristada 281.25 MG/ML Extended Release Suspension Prefilled Syringe	SY	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049341	aripiprazole lauroxil 675 MG per 2.4 ML Prefilled Syringe	SY	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049343	Aristada 675 MG per 2.4 ML Prefilled Syringe	SY	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16
2049343	Aristada Initio Starter Dose 281.3 MG/ML per 2.4 ML Prefilled Syringe	SY	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65757-500-00	65757050000	20 TRAY in 1 CARTON (65757-500-00) / 15 SYRINGE in 1 TRAY / 2.4 mL in 1 SYRINGE	20 tray	29-JUN-18				Current
65757-500-03	65757050003	1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE	1 syringe	2018-06-29	0000-00-00	No	No	Current
65757-500-04	65757050004	1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE	1 syringe	2018-06-29	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARISTADA INITIO	Alkermes, Inc. \| Alkermes, Inc \| Sharp Corporation	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	16