Prescription drug · ANDA
Risperidone NDC 87564-015
Risperidone 2 mg/1 · Tablet, Orally disintegrating · Oral · Amerisyn LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87564-015-28 | 87564001528 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (87564-015-28)Marketed from Aug 6, 2026 |
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 — 2 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Amerisyn LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077328
- Marketing start
- Listing expires
- Identifiers
- Product ID 87564-015_58b7505e-32cb-ef57-e063-6394a90abca1SPL ID 58b7505e-32cb-ef57-e063-6394a90abca1SPL set ID 58b7504f-c4a3-ef1b-e063-6394a90ac0f3RxCUI 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
N487564001528followed by a unit qualifier and the quantityPackage 87564-0015-28. 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)
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 orally disintegrating 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 orally disintegrating tablets are …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077328
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 |
|---|---|---|---|---|
| Risperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-574 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-575 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-014 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-013 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-016 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-017 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-573 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-571 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-572 |