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NDC 50458-0306-11 RISPERDAL CONSTA Details
RISPERDAL CONSTA
RISPERDAL CONSTA is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, 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: 50458-0306-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Risperidone Injection
Product Information
| NDC | 50458-0306 |
|---|---|
| Product ID | 50458-306_0a342d67-f908-9269-e063-6294a90ace24 |
| Associated GPIs | 5907007010G220 |
| GCN Sequence Number | 052934 |
| GCN Sequence Number Description | risperidone microspheres VIAL 25 MG/2 ML INTRAMUSC |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 20217 |
| HICL Sequence Number | 025509 |
| HICL Sequence Number Description | RISPERIDONE MICROSPHERES |
| Brand/Generic | Brand |
| Proprietary Name | RISPERDAL CONSTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | risperidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021346 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0306-11 (50458030611)
| NDC Package Code | 50458-306-11 |
|---|---|
| Billing NDC | 50458030611 |
| Package | 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE |
| Marketing Start Date | 2003-10-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 589.038 |
| Pricing Unit | EA |
| Effective Date | 2023-10-13 |
| NDC Description | RISPERDAL CONSTA 25 MG VIAL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |