Prescription drug · ANDA
risperidone NDC 0904-7365
Risperidone 4 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7365-61 | 00904736561 | 100 BLISTER PACK in 1 CARTON (0904-7365-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 27, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078040
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7365_41d98aaf-a69e-414d-af3f-2c815cd1f43aSPL ID 41d98aaf-a69e-414d-af3f-2c815cd1f43aSPL set ID d5abd75f-7f4a-4a7d-b849-82fce88f5ff7RxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII 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
N400904736561followed by a unit qualifier and the quantityPackage 00904-7365-61. 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 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 epis…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078040
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, Film coatedOral | Zydus Lifesciences Limited | 65841-669 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-666 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-667 |
| risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-668 |
| risperidone | Risperidone 4 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-670 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-273 |
| Risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-270 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-271 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-272 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-274 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-277 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7360 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0180 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7361 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7362 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-418 |
| risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7363 |
| risperidone | Risperidone 3 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7364 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-114 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-112 |
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