Rykindo

Product NDC: 72526-104
11-digit product format: 725260104
Labeler code: 72526
Product ID: 72526-104_4701fbbb-2d07-4b47-9596-4255a49c7dbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: KIT
Labeler: Shandong Luye Pharmaceutical Co., Ltd.
Application: NDA212849
Marketing category: NDA
Marketing start: 2023-06-20
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72526-104	72526-104-11	D	Discontinued by firm		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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212849-001	RYKINDO	RISPERIDONE	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13
N212849-002	RYKINDO	RISPERIDONE	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13
N212849-003	RYKINDO	RISPERIDONE	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13
N212849-004	RYKINDO	RISPERIDONE	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13

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
N212849-001	10098882	2032-04-10	U-3513	Drug product	2023-02-07
N212849-001	10406161	2032-04-10	U-3513	Drug product	2023-02-07
N212849-001	11110094	2032-04-10		Drug product	2023-02-07
N212849-001	9446135	2032-04-10	U-3513	Drug product	2023-02-07
N212849-001	9532991	2032-04-10	U-3513	Drug product	2023-02-07
N212849-002	10098882	2032-04-10	U-3513	Drug product	2023-02-07
N212849-002	10406161	2032-04-10	U-3513	Drug product	2023-02-07
N212849-002	11110094	2032-04-10		Drug product	2023-02-07
N212849-002	9446135	2032-04-10	U-3513	Drug product	2023-02-07
N212849-002	9532991	2032-04-10	U-3513	Drug product	2023-02-07
N212849-003	10098882	2032-04-10	U-3513	Drug product	2023-02-07
N212849-003	10406161	2032-04-10	U-3513	Drug product	2023-02-07
N212849-003	11110094	2032-04-10		Drug product	2023-02-07
N212849-003	9446135	2032-04-10	U-3513	Drug product	2023-02-07
N212849-003	9532991	2032-04-10	U-3513	Drug product	2023-02-07
N212849-004	10098882	2032-04-10	U-3513	Drug product	2023-02-07
N212849-004	10406161	2032-04-10	U-3513	Drug product	2023-02-07
N212849-004	11110094	2032-04-10		Drug product	2023-02-07
N212849-004	9446135	2032-04-10	U-3513	Drug product	2023-02-07
N212849-004	9532991	2032-04-10	U-3513	Drug product	2023-02-07

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 · 92 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	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212849-001	RYKINDO	12.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212849-002	RYKINDO	25MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212849-003	RYKINDO	37.5MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212849-004	RYKINDO	50MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-01-13	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 460 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	N212849-001	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-001	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-001	11110094	2032-04-10		Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-001	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-001	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	11110094	2032-04-10		Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-002	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	11110094	2032-04-10		Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-003	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	11110094	2032-04-10		Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212849-004	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	11110094	2032-04-10		Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-001	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	11110094	2032-04-10		Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-002	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	11110094	2032-04-10		Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-003	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	10098882	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	10406161	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	11110094	2032-04-10		Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	9446135	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212849-004	9532991	2032-04-10	U-3513	Drug product	2023-02-07	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rykindo
Brand name suffix: extended-release microspheres
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402010	Internal RxNorm lookup
402011	Internal RxNorm lookup
402012	Internal RxNorm lookup
2639734	Internal RxNorm lookup
2639736	Internal RxNorm lookup
2639738	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
58534c96-96f5-4c2e-a061-92d4506aee91	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
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
72526-104-11	Rykindo extended-release microspheres	1 in 1 KIT	KIT	1		10
72526-204-01	Rykindo extended-release microspheres	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	2 mL	50 mg in 2mL	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72526-104-11	EA - Each	72526-104	24172dcd-f994-4dc8-973a-62a989247d91	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72526-104	RYKINDO EXTENDED-RELEASE MICROSPHERES (RISPERIDONE) KIT [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]	6	Current NDC, 2 package rows	20250206_58534c96-96f5-4c2e-a061-92d4506aee91.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
Rykindo extended-release microspheres	RISPERIDONE	Shandong Luye Pharmaceutical Co., Ltd.	58534c96-96f5-4c2e-a061-92d4506aee91	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212849 application number: NDA212849 ndc (product): 72526-104

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
402010	risperiDONE 25 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
402011	risperiDONE 37.5 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
402012	risperiDONE 50 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639734	Rykindo 25 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639736	Rykindo 37.5 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639738	Rykindo 50 MG Extended Release Injection	PSN	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639734	risperidone 25 MG Injection [Rykindo]	SBD	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639736	risperidone 37.5 MG Injection [Rykindo]	SBD	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639738	risperidone 50 MG Injection [Rykindo]	SBD	58534c96-96f5-4c2e-a061-92d4506aee91	10
402010	risperidone 25 MG Injection	SCD	58534c96-96f5-4c2e-a061-92d4506aee91	10
402011	risperidone 37.5 MG Injection	SCD	58534c96-96f5-4c2e-a061-92d4506aee91	10
402012	risperidone 50 MG Injection	SCD	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639734	Rykindo 25 MG Injection	SY	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639736	Rykindo 37.5 MG Injection	SY	58534c96-96f5-4c2e-a061-92d4506aee91	10
2639738	Rykindo 50 MG Injection	SY	58534c96-96f5-4c2e-a061-92d4506aee91	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
72526-104-11	72526010411	1 in 1 KIT		Historical
72526-204-01	72526020401	2 mL in 1 VIAL, SINGLE-DOSE	2 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rykindo extended-release microspheres	Shandong Luye Pharmaceutical Co., Ltd.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	10