Prescription drug · ANDA
risperidone NDC 68382-114
Risperidone 1 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-114-01 | 68382011401 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-114-01)Marketed from Nov 13, 2008 | |
| 68382-114-05 | 68382011405 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-114-05)Marketed from Nov 13, 2008 | |
| 68382-114-06 | 68382011406 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-114-06)Marketed from Nov 13, 2008 | |
| 68382-114-10 | 68382011410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-114-10)Marketed from Nov 13, 2008 | |
| 68382-114-14 | 68382011414 | 60 TABLET, FILM COATED in 1 BOTTLE (68382-114-14)Marketed from Nov 13, 2008 | |
| 68382-114-16 | 68382011416 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-114-16)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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078040
- Marketing start
- Listing expires
- Identifiers
- Product ID 68382-114_2af53e64-46a6-4b12-9ac8-8f8031a8bd97SPL ID 2af53e64-46a6-4b12-9ac8-8f8031a8bd97SPL set ID 713b5ac7-53d6-4139-8599-3028f789de4bRxCUI 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
N468382011401followed by a unit qualifier and the quantityPackage 68382-0114-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 4 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7365 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-112 |
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