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NDC 51759-0630-11 UZEDY 125 mg/.35mL Details
UZEDY 125 mg/.35mL
UZEDY is a SUBCUTANEOUS INJECTION, SUSPENSION, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals USA, Inc.. The primary component is RISPERIDONE.
MedlinePlus Drug Summary
Risperidone extended-release injection (Perseris, Risperdal Consta, Rykindo, Uzedy) 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 (Risperdal Consta, Rykindo) is used alone or in combination with lithium (Lithobid) or valproate 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: 51759-0630-11Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Risperidone Injection
Product Information
| NDC | 51759-0630 |
|---|---|
| Product ID | 51759-630_a0b81ec6-78d0-4be1-8cad-135a94cf403c |
| Associated GPIs | |
| GCN Sequence Number | 084728 |
| GCN Sequence Number Description | risperidone SUSER SYR 125MG/0.35 SUBCUT |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 51479 |
| HICL Sequence Number | 008721 |
| HICL Sequence Number Description | RISPERIDONE |
| Brand/Generic | Brand |
| Proprietary Name | UZEDY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | risperidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SUSPENSION, EXTENDED RELEASE |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 125 |
| Active Ingredient Units | mg/.35mL |
| Substance Name | RISPERIDONE |
| Labeler Name | Teva Pharmaceuticals USA, Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213586 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 51759-0630-11 (51759063011)
| NDC Package Code | 51759-630-11 |
|---|---|
| Billing NDC | 51759063011 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (51759-630-11) / .35 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2023-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |