FDA.reportPublic FDA data

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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui402010, 402011, 402012, 2639734, 2639736, 2639738

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09eProduct name120250128
e457a910-2c3a-4bfd-90b9-0310982c50ddProduct name120241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72526-104-11Rykindo extended-release microspheres1 in 1 KITKIT110
72526-204-01Rykindo extended-release microspheres2 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,2 mL50 mg in 2mL10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72526-104-11EA - Each72526-10424172dcd-f994-4dc8-973a-62a989247d9112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72526-104RYKINDO EXTENDED-RELEASE MICROSPHERES (RISPERIDONE) KIT [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]6Current NDC, 2 package rows20250206_58534c96-96f5-4c2e-a061-92d4506aee91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402010risperiDONE 25 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
402011risperiDONE 37.5 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
402012risperiDONE 50 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
2639734Rykindo 25 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
2639736Rykindo 37.5 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
2639738Rykindo 50 MG Extended Release InjectionPSN58534c96-96f5-4c2e-a061-92d4506aee9110
2639734risperidone 25 MG Injection [Rykindo]SBD58534c96-96f5-4c2e-a061-92d4506aee9110
2639736risperidone 37.5 MG Injection [Rykindo]SBD58534c96-96f5-4c2e-a061-92d4506aee9110
2639738risperidone 50 MG Injection [Rykindo]SBD58534c96-96f5-4c2e-a061-92d4506aee9110
402010risperidone 25 MG InjectionSCD58534c96-96f5-4c2e-a061-92d4506aee9110
402011risperidone 37.5 MG InjectionSCD58534c96-96f5-4c2e-a061-92d4506aee9110
402012risperidone 50 MG InjectionSCD58534c96-96f5-4c2e-a061-92d4506aee9110
2639734Rykindo 25 MG InjectionSY58534c96-96f5-4c2e-a061-92d4506aee9110
2639736Rykindo 37.5 MG InjectionSY58534c96-96f5-4c2e-a061-92d4506aee9110
2639738Rykindo 50 MG InjectionSY58534c96-96f5-4c2e-a061-92d4506aee9110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
72526-104-11725260104111 in 1 KITHistorical
72526-204-01725260204012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical