risperidone 3 mg/1
risperidone · TABLET, FILM COATED · Major Pharmaceuticals
Risperidone is an atypical antipsychotic medication used to treat conditions such as schizophrenia, bipolar disorder, and irritability associated with autism. It is taken by mouth as an oral tablet and works by helping to balance certain chemicals in the brain.
Key Facts
- Brand Name
- risperidone
- Generic Name
- risperidone
- NDC Code (Product)
0904-7364- Manufacturer
- Major Pharmaceuticals
- Strength
- 3 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078040
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 11/13/2008
Recall History
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Janssen Pharmaceuticals, Inc.
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Zydus Pharmaceuticals USA Inc
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Apotex Inc.
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Frequently Asked Questions
What is risperidone used for?
Risperidone is an atypical antipsychotic medication used to treat conditions such as schizophrenia, bipolar disorder, and irritability associated with autism. It is taken by mouth as an oral tablet and works by helping to balance certain chemicals in the brain.
Is risperidone a controlled substance?
risperidone is not classified as a controlled substance by the DEA.
What is the generic name for risperidone?
The generic name for risperidone is risperidone. There are 11 other brand versions of risperidone.
What is the NDC code for risperidone 3 mg/1?
The NDC (National Drug Code) for risperidone 3 mg/1 is 0904-7364, listed by Major Pharmaceuticals.