Prescription drug · NDA
Risperdal (Risperidone) NDC 50458-300
Risperidone 1 mg/1 · Tablet · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-300-01 | 50458030001 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-300-01) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 29, 1993 | |
| 50458-300-06 | 50458030006 | 60 TABLET in 1 BOTTLE (50458-300-06)Marketed from Dec 29, 1993 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Risperdal
- Generic name (nonproprietary)
- risperidone
- Active ingredients
- Risperidone — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020272
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-300_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.
- NDC on a medical claim
N450458030001followed by a unit qualifier and the quantityPackage 50458-0300-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
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 50458-300
- What is NDC 50458-300?
- 50458-300 is the product NDC for Risperdal (risperidone), Risperidone 1 mg/1 tablet, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Risperdal (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?
- 5 other product NDCs are listed under this name. See all Risperdal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Risperdal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Risperdalrisperidone | Risperidone 1 mg/mL | SolutionOral | Janssen Pharmaceuticals, Inc. | 50458-305 | 50458-0305-03 |
| Risperdalrisperidone | Risperidone .5 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-302 | 50458-0302-0150458-0302-06 |
| Risperdalrisperidone | Risperidone 2 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-320 | 50458-0320-0150458-0320-06 |
| Risperdalrisperidone | Risperidone 3 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-330 | 50458-0330-06 |
| Risperdalrisperidone | Risperidone 4 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-350 | 50458-0350-0150458-0350-06 |
Other NDCs under NDA 020272
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 |
|---|---|---|---|---|
| Risperdalrisperidone | Risperidone .5 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-302 |
| Risperdalrisperidone | Risperidone 2 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-320 |
| Risperdalrisperidone | Risperidone 3 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-330 |
| Risperdalrisperidone | Risperidone 4 mg/1 | TabletOral | Janssen Pharmaceuticals, Inc. | 50458-350 |