FDA.reportPublic FDA data

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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2055667, 2055672, 2055675, 2055676

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12496-0120-12022-08-26C16284748780-1e4f33bdf-af3c-d8a0-e053-dadaa90a6e4eThese 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
12496-0120-92022-08-26C16284748780-1e4f33bdf-af3c-d8a0-e053-dadaa90a6e4eThese 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
12496-0120-12022-07-29C16284748780-1e4f33bdf-af3c-d8a0-e053-dadaa90a6e4eThese 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
12496-0120-92022-07-29C16284748780-1e4f33bdf-af3c-d8a0-e053-dadaa90a6e4eThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
12496-0120-1PERSERIS1 in 1 CARTONKIT118
12496-0120-2PERSERIS1 in 1 POUCHPOWDER120 mg in 0.8mL18
12496-0120-5PERSERIS1.2 mL in 1 SYRINGEPOWDER1.2 mL120 mg in 0.8mL18
12496-0120-9PERSERIS1 in 1 CARTONKIT118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12496-0120-1EA - Each12496-0120cf17bffa-a95f-43e9-a98a-54fd8ec4428912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12496-0120PERSERIS (RISPERIDONE) KIT [INDIVIOR INC.]18Current NDC, Legacy NDC, 4 package rows20250221_a4f21b1a-5691-4b14-a56d-651962d06f39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055672PERSERIS 120 MG in 0.8 mL Prefilled SyringePSNa4f21b1a-5691-4b14-a56d-651962d06f3918
2055676PERSERIS 90 MG in 0.6 mL Prefilled SyringePSNa4f21b1a-5691-4b14-a56d-651962d06f3918
2055667risperiDONE 120 MG in 0.8 mL Prefilled SyringePSNa4f21b1a-5691-4b14-a56d-651962d06f3918
2055675risperiDONE 90 MG in 0.6 mL Prefilled SyringePSNa4f21b1a-5691-4b14-a56d-651962d06f3918
20556760.6 ML risperidone 150 MG/ML Prefilled Syringe [Perseris]SBDa4f21b1a-5691-4b14-a56d-651962d06f3918
20556720.8 ML risperidone 150 MG/ML Prefilled Syringe [Perseris]SBDa4f21b1a-5691-4b14-a56d-651962d06f3918
20556750.6 ML risperidone 150 MG/ML Prefilled SyringeSCDa4f21b1a-5691-4b14-a56d-651962d06f3918
20556670.8 ML risperidone 150 MG/ML Prefilled SyringeSCDa4f21b1a-5691-4b14-a56d-651962d06f3918
20556760.6 ML Perseris 150 MG/ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918
20556720.8 ML Perseris 150 MG/ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918
2055672Perseris 120 MG per 0.8 ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918
2055676Perseris 90 MG per 0.6 ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918
2055667risperidone 120 MG per 0.8 ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918
2055675risperidone 90 MG per 0.6 ML Prefilled SyringeSYa4f21b1a-5691-4b14-a56d-651962d06f3918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12496-0120-1124960120011 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 kit2018-11-090000-00-00NoNoCurrent
12496-0120-2124960120021 in 1 POUCHHistorical
12496-0120-5124960120051.2 mL in 1 SYRINGE1.2 mlHistorical
12496-0120-9124960120091 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 kit2019-02-120000-00-00YesNoCurrent