Risperidone NDC 69367-373

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-373Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0373Add 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
69367-373-05	69367037305	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-373-05)Marketed from Sep 9, 2024
69367-373-60	69367037360	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-373-60)Marketed from Apr 21, 2025

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 — 4 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Westminster Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078707
Marketing start: Sep 9, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 69367-373_4559701f-b153-5434-e063-6294a90a6d1dSPL ID 4559701f-b153-5434-e063-6294a90a6d1dSPL set ID 07d43bf6-a695-453a-a5c7-9581effe585cRxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII L6UH7ZF8HCUPC 0369367369053, 0369367373050, 0369367368056, 0369367372053
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

N469367037305 followed by a unit qualifier and the quantity

Package 69367-0373-05. 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 Dec 7, 2025. 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 tablets are 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 tablets are indicated for the treatment of acute manic or…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078707

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

FDA NDC Directory listings under ANDA 078707
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-370
Risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-368
Risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-369
Risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-371
Risperidone	Risperidone 3 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-372
Risperidone	Risperidone 4 mg/1	Tablet, Film coatedOral	AvKARE	42291-979
Risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	AvKARE	42291-976
Risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	AvKARE	42291-977
Risperidone	Risperidone 3 mg/1	Tablet, Film coatedOral	AvKARE	42291-978
Risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	AvKARE	42291-975
Risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	AvKARE	42291-974