Prescription drug · ANDA
risperidone NDC 65841-668
Risperidone 2 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-668-01 | 65841066801 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-668-01)Marketed from Nov 13, 2008 | |
| 65841-668-05 | 65841066805 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-668-05)Marketed from Nov 13, 2008 | |
| 65841-668-06 | 65841066806 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-668-06)Marketed from Nov 13, 2008 | |
| 65841-668-10 | 65841066810 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-668-10)Marketed from Nov 13, 2008 | |
| 65841-668-14 | 65841066814 | 60 TABLET, FILM COATED in 1 BOTTLE (65841-668-14)Marketed from Nov 13, 2008 | |
| 65841-668-16 | 65841066816 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-668-16)Marketed from Nov 13, 2008 |
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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078040
- Marketing start
- Listing expires
- Identifiers
- Product ID 65841-668_d39bd21c-64bb-4eff-8713-5a5ed9b98c9dSPL ID d39bd21c-64bb-4eff-8713-5a5ed9b98c9dSPL set ID 23993d21-80bf-41c4-b57d-88a620173b6bRxCUI 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
N465841066801followed by a unit qualifier and the quantityPackage 65841-0668-01. 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 .
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 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 4 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7365 |
| 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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