Prescription drug · ANDA
Risperidone NDC 42291-977
Risperidone 2 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-977-50 | 42291097750 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-977-50)Marketed from Aug 27, 2025 | |
| 42291-977-60 | 42291097760 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-977-60)Marketed from Aug 27, 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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078707
- Marketing start
- Listing expires
- Identifiers
- Product ID 42291-977_3d4c5818-d71d-e4d0-e063-6394a90a9679SPL ID 3d4c5818-d71d-e4d0-e063-6394a90a9679SPL set ID 3d4c51e2-b09b-9fd0-e063-6294a90ae699RxCUI 312831, 312832, 314211UNII L6UH7ZF8HCUPC 0342291978508, 0342291977501, 0342291979505
- 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
N442291097750followed by a unit qualifier and the quantityPackage 42291-0977-50. 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 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.
Other NDCs under ANDA 078707
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 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 | Westminster Pharmaceuticals, LLC | 69367-373 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-979 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-976 |
| 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 |