Prescription drug · NDA
Risperdal M-Tab (risperidone) NDC 50458-395
Risperidone .5 mg/1 · Tablet, Orally disintegrating · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Risperdal M-Tab
- Generic name (nonproprietary)
- risperidone
- Active ingredients
- Risperidone — .5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021444
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-395_15ff9571-c82c-48d9-84d3-a7a6abaae93eSPL ID 15ff9571-c82c-48d9-84d3-a7a6abaae93eSPL set ID 7e117c7e-02fc-4343-92a1-230061dfc5e0RxCUI 104781, 104782, 104783, 104784, 199387, 211489, 262222, 312829, 312830, 312831, 312832, 314211, 401953, 401954, 403825, 616698, 616705, 630890, 630974, 806297, 806298, 806299UNII L6UH7ZF8HC
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . 1.2 Bipolar Mania Monotherapy RISPERDAL is indicated for the treatment of acute manic or mixed epi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021444
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Risperdal M-Tabrisperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-325 |
| Risperdal M-Tabrisperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-315 |
| Risperdal M-Tabrisperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-355 |
| Risperdal M-Tabrisperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-335 |