FDA.reportPublic FDA data

RISPERDAL CONSTA

Product NDC
50458-309
11-digit product format
504580309
Labeler code
50458
Product ID
50458-309_42dc490b-4117-142a-e063-6294a90aeb21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
KIT
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA021346
Marketing category
NDA
Marketing start
2003-10-29
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RISPERDAL CONSTA
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui402010, 402011, 402012, 706822, 706825, 706827, 706829, 706831

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-309-11RISPERDAL CONSTA1 in 1 BOXKIT138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-309RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.]37Current NDC, Legacy NDC, 1 package rows20250417_bb34ee82-d2c2-43b8-ba21-2825c0954691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
706825RisperDAL CONSTA 12.5 MG InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
706831RisperDAL CONSTA 25 MG InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
706827RisperDAL CONSTA 37.5 MG InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
706829RisperDAL CONSTA 50 MG InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
706822risperiDONE 12.5 MG Extended Release InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
402010risperiDONE 25 MG Extended Release InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
402011risperiDONE 37.5 MG Extended Release InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
402012risperiDONE 50 MG Extended Release InjectionPSNbb34ee82-d2c2-43b8-ba21-2825c095469138
706825risperidone 12.5 MG Injection [Risperdal]SBDbb34ee82-d2c2-43b8-ba21-2825c095469138
706831risperidone 25 MG Injection [Risperdal]SBDbb34ee82-d2c2-43b8-ba21-2825c095469138
706827risperidone 37.5 MG Injection [Risperdal]SBDbb34ee82-d2c2-43b8-ba21-2825c095469138
706829risperidone 50 MG Injection [Risperdal]SBDbb34ee82-d2c2-43b8-ba21-2825c095469138
706822risperidone 12.5 MG InjectionSCDbb34ee82-d2c2-43b8-ba21-2825c095469138
402010risperidone 25 MG InjectionSCDbb34ee82-d2c2-43b8-ba21-2825c095469138
402011risperidone 37.5 MG InjectionSCDbb34ee82-d2c2-43b8-ba21-2825c095469138
402012risperidone 50 MG InjectionSCDbb34ee82-d2c2-43b8-ba21-2825c095469138
706825Risperdal 12.5 MG InjectionSYbb34ee82-d2c2-43b8-ba21-2825c095469138
706831Risperdal 25 MG InjectionSYbb34ee82-d2c2-43b8-ba21-2825c095469138
706827Risperdal 37.5 MG InjectionSYbb34ee82-d2c2-43b8-ba21-2825c095469138
706829Risperdal 50 MG InjectionSYbb34ee82-d2c2-43b8-ba21-2825c095469138

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-309-11504580309111 KIT in 1 BOX (50458-309-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-309-01) 1 kit2003-10-290000-00-00NoNoCurrent