Risperidone NDC 70518-3760

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3760Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3760Add 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
70518-3760-0	70518376000	10 CUP, UNIT-DOSE in 1 BOX (70518-3760-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3760-1)Marketed from Jun 12, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020588
Marketing start: Jun 12, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 70518-3760_4f8356fa-4c24-9f88-e063-6294a90a09d6SPL ID 4f8356fa-4c24-9f88-e063-6294a90a09d6SPL set ID ab1cf6fd-9932-47fc-8736-476cc53a13faRxCUI 199387UNII 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

N470518376000 followed by a unit qualifier and the quantity

Package 70518-3760-00. 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 Apr 15, 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)

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	Janssen Pharmaceuticals, Inc.	50458-596