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
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- 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.
About NDC 50458-395
- What is NDC 50458-395?
- 50458-395 is the product NDC for Risperdal M-Tab (risperidone), Risperidone .5 mg/1 tablet, orally disintegrating, listed with the FDA by Janssen Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Risperdal M-Tab (Risperidone).
- What is the active ingredient?
- Risperidone.
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Risperdal M-Tab?
- 4 other product NDCs are listed under this name. See all Risperdal M-Tab NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Risperdal M-Tab products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Risperdal M-Tabrisperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-315 | — |
| Risperdal M-Tabrisperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-325 | — |
| Risperdal M-Tabrisperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-335 | — |
| Risperdal M-Tabrisperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-355 | — |
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 1 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-315 |
| Risperdal M-Tabrisperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-325 |
| Risperdal M-Tabrisperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-335 |
| Risperdal M-Tabrisperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Janssen Pharmaceuticals, Inc. | 50458-355 |