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NDC 68382-0112-01 risperidone 0.25 mg/1 Details
risperidone 0.25 mg/1
risperidone is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is RISPERIDONE.
MedlinePlus Drug Summary
Risperidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in adults and in teenagers and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Risperidone is also used to treat behavior problems such as aggression, self-injury, and sudden mood changes in teenagers and children 5 to 16 years of age who have autism (a condition that causes repetitive behavior, difficulty interacting with others, and problems with communication). 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: 68382-0112-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Risperidone
Product Information
| NDC | 68382-0112 |
|---|---|
| Product ID | 68382-112_fc6e6540-fc7f-4329-b05b-5ec4ffd57000 |
| Associated GPIs | 59070070000303 |
| GCN Sequence Number | 042922 |
| GCN Sequence Number Description | risperidone TABLET 0.25 MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 92872 |
| HICL Sequence Number | 008721 |
| HICL Sequence Number Description | RISPERIDONE |
| Brand/Generic | Generic |
| Proprietary Name | risperidone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | risperidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/1 |
| Substance Name | RISPERIDONE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078040 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0112-01 (68382011201)
| NDC Package Code | 68382-112-01 |
|---|---|
| Billing NDC | 68382011201 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (68382-112-01) |
| Marketing Start Date | 2008-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |