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NDC 12496-0120-09 PERSERIS Details
PERSERIS
PERSERIS is a SUBCUTANEOUS KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Indivior Inc.. The primary component is .
MedlinePlus Drug Summary
Risperidone extended-release (long-acting) injection is used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Risperidone extended-release injection is used alone or in combination with lithium (Lithobid) or valproate (Depacon) to treat people who have bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods). Risperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 12496-0120-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Risperidone Injection
Product Information
NDC | 12496-0120 |
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Product ID | 12496-0120_47e1df06-f128-4504-bea9-df41a58840b0 |
Associated GPIs | 5907007000E430 |
GCN Sequence Number | 078741 |
GCN Sequence Number Description | risperidone SUSER SYR 120 MG SUBCUT |
HIC3 | H7T |
HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
GCN | 45128 |
HICL Sequence Number | 008721 |
HICL Sequence Number Description | RISPERIDONE |
Brand/Generic | Brand |
Proprietary Name | PERSERIS |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Risperidone |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | KIT |
Route | SUBCUTANEOUS |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | Indivior Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA210655 |
Listing Certified Through | 2024-12-31 |
Package
NDC 12496-0120-09 (12496012009)
NDC Package Code | 12496-0120-9 |
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Billing NDC | 12496012009 |
Package | 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) |
Marketing Start Date | 2019-02-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |