PERSERIS

Product NDC: 12496-0120
11-digit product format: 124960120
Labeler code: 12496
Product ID: 12496-0120_2893c2b5-aa3e-4ec7-bfd3-0132306a31a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: Indivior Inc.
Application: NDA210655
Marketing category: NDA
Marketing start: 2018-11-09
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12496-0120		I	Inactivated by FDA	2026-08-03
excluded package	package	12496-0120	12496-0120-1	I	Inactivated by FDA	2026-08-03
excluded package	package	12496-0120	12496-0120-9	I	Inactivated by FDA	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210655-001	PERSERIS KIT	RISPERIDONE	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2018-07-27
N210655-002	PERSERIS KIT	RISPERIDONE	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2018-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26
N210655-001	10058554	2026-09-26	U-2363		2018-08-28
N210655-001	9597402	2026-09-26		Drug product	2018-07-31
N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07
N210655-001	10010612	2028-02-13		Drug product	2018-07-31
N210655-001	10376590	2028-02-13	U-2608		2019-08-29
N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01
N210655-001	11712475	2028-02-13	U-3135		2023-08-31
N210655-001	9180197	2028-02-13		Drug product	2018-07-31
N210655-001	9186413	2028-02-13	U-543		2018-07-31
N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26
N210655-002	10058554	2026-09-26	U-2363		2018-08-28
N210655-002	9597402	2026-09-26		Drug product	2018-07-31
N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07
N210655-002	10010612	2028-02-13		Drug product	2018-07-31
N210655-002	10376590	2028-02-13	U-2608		2019-08-29
N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01
N210655-002	11712475	2028-02-13	U-3135		2023-08-31
N210655-002	9180197	2028-02-13		Drug product	2018-07-31
N210655-002	9186413	2028-02-13	U-543		2018-07-31

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 740 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`31067a03dcf5…`

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	N210655-001	NP	2021-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210655-002	NP	2021-07-27	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210655-001	NP	2021-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210655-002	NP	2021-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210655-001	NP	2021-07-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210655-002	NP	2021-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210655-001	NP	2021-07-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210655-002	NP	2021-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210655-001	NP	2021-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210655-002	NP	2021-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210655-001	NP	2021-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210655-002	NP	2021-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210655-001	NP	2021-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210655-002	NP	2021-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210655-001	NP	2021-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210655-002	NP	2021-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210655-001	NP	2021-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210655-002	NP	2021-07-27	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
12496-0120-1	2022-08-26	These highlights do not include all the information needed to use PERSERIS ® safely and effectively. See full prescribing information for PERSERIS. PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use. Initial U.S. Approval: 1993
12496-0120-9	2022-08-26	These highlights do not include all the information needed to use PERSERIS ® safely and effectively. See full prescribing information for PERSERIS. PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use. Initial U.S. Approval: 1993
12496-0120-1	2022-07-29	These highlights do not include all the information needed to use PERSERIS ® safely and effectively. See full prescribing information for PERSERIS. PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use. Initial U.S. Approval: 1993
12496-0120-9	2022-07-29	These highlights do not include all the information needed to use PERSERIS ® safely and effectively. See full prescribing information for PERSERIS. PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use. Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12496-0120-1	PERSERIS	1 in 1 CARTON	KIT	1		18
12496-0120-2	PERSERIS	1 in 1 POUCH	POWDER		120 mg in 0.8mL	18
12496-0120-5	PERSERIS	1.2 mL in 1 SYRINGE	POWDER	1.2 mL	120 mg in 0.8mL	18
12496-0120-9	PERSERIS	1 in 1 CARTON	KIT	1		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12496-0120-1	EA - Each	12496-0120	cf17bffa-a95f-43e9-a98a-54fd8ec44289	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12496-0120	PERSERIS (RISPERIDONE) KIT [INDIVIOR INC.]	18	Current NDC, Legacy NDC, 4 package rows	20250221_a4f21b1a-5691-4b14-a56d-651962d06f39.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	Risperidone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055672	PERSERIS 120 MG in 0.8 mL Prefilled Syringe	PSN	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055676	PERSERIS 90 MG in 0.6 mL Prefilled Syringe	PSN	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055667	risperiDONE 120 MG in 0.8 mL Prefilled Syringe	PSN	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055675	risperiDONE 90 MG in 0.6 mL Prefilled Syringe	PSN	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055676	0.6 ML risperidone 150 MG/ML Prefilled Syringe [Perseris]	SBD	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055672	0.8 ML risperidone 150 MG/ML Prefilled Syringe [Perseris]	SBD	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055675	0.6 ML risperidone 150 MG/ML Prefilled Syringe	SCD	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055667	0.8 ML risperidone 150 MG/ML Prefilled Syringe	SCD	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055676	0.6 ML Perseris 150 MG/ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055672	0.8 ML Perseris 150 MG/ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055672	Perseris 120 MG per 0.8 ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055676	Perseris 90 MG per 0.6 ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055667	risperidone 120 MG per 0.8 ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18
2055675	risperidone 90 MG per 0.6 ML Prefilled Syringe	SY	a4f21b1a-5691-4b14-a56d-651962d06f39	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12496-0120-1	12496012001	1 KIT in 1 CARTON (12496-0120-1) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5)	1 kit	2018-11-09	0000-00-00	No	No	Current
12496-0120-2	12496012002	1 in 1 POUCH						Historical
12496-0120-5	12496012005	1.2 mL in 1 SYRINGE	1.2 ml					Historical
12496-0120-9	12496012009	1 KIT in 1 CARTON (12496-0120-9) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5)	1 kit	2019-02-12	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PERSERIS	Indivior Inc. \| Curia Massachusetts, Inc. \| Curia Global, Inc. \| Assia Chemical Industries Ltd (Teva Tech site) \| Eurofins Lancaster Laboratories, Inc \| Isomedix Operations Inc \| Nelson Laboratories, LLC \| Patheon Manufacturing Services LLC \| SGS North America Inc \| Sharp Packaging Services, LLC \| Spectral Data Services, Inc. \| SYNERGY HEALTH AST, LLC \| Teva API India Private Ltd.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	18