What is NDC 50458-596?

50458-596 is the product NDC for Risperidone, Risperidone 1 mg/mL solution, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Risperidone?

168 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Risperidone NDC 50458-596 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-596Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0596Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50458-596-01	5045805960150458059601	30 mL in 1 BOTTLE (50458-596-01)Marketed from Jun 10, 1996

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): Risperidone
Generic name (nonproprietary): risperidone
Active ingredients: Risperidone — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020588
Marketing start: Jun 10, 1996
Listing expires: Dec 31, 2027
Identifiers: Product ID 50458-596_8fcb6445-1b36-4229-8887-041181df74acSPL ID 8fcb6445-1b36-4229-8887-041181df74acSPL set ID 701e1cd8-2868-4d29-85a9-a2212c88165fRxCUI 199387, 312829, 312830, 312831, 312832, 314211, 401953, 401954, 403825, 616698, 616705UNII 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

N450458059601 followed by a unit qualifier and the quantity

Package 50458-0596-01. 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 Aug 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone 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 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 Risperidone is indicated for the treatment of acute manic or mixed episodes as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50458-596

What is NDC 50458-596?: 50458-596 is the product NDC for Risperidone, Risperidone 1 mg/mL solution, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: 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 Risperidone?: 168 other product NDCs are listed under this name. See all Risperidone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Risperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-013	87564-0013-28
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-014	87564-0014-28
Risperidone	Risperidone 2 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-015	87564-0015-28
Risperidone	Risperidone 3 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-016	87564-0016-28
Risperidone	Risperidone 4 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-017	87564-0017-28
Risperidone	Risperidone .5 mg/1	TabletOral	Coupler LLC	67046-0644	67046-0644-03
Risperidone	Risperidone .25 mg/1	TabletOral	Coupler LLC	67046-2064	67046-2064-03
Risperidone	Risperidone 1 mg/1	TabletOral	Coupler LLC	67046-0635	67046-0635-03
Risperidone	Risperidone 2 mg/1	TabletOral	Coupler LLC	67046-0630	67046-0630-03
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amici Pharma, Inc.	69292-571	69292-0571-30

All 169 Risperidone NDCs

Other NDCs under NDA 020588

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020588
Product	Strength	Form · route	Labeler	Product NDC
Risperdalrisperidone	Risperidone 1 mg/mL	SolutionOral	Janssen Pharmaceuticals, Inc.	50458-305
Risperidone	Risperidone 1 mg/mL	SolutionOral	REMEDYREPACK INC.	70518-3760