Prescription drug · ANDA
Risperidone NDC 70518-3883
Risperidone 1 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3883-0 | 70518388300 | 30 TABLET in 1 BLISTER PACK (70518-3883-0)Marketed from Sep 28, 2023 | |
| 70518-3883-1 | 70518388301 | 60 TABLET in 1 BLISTER PACK (70518-3883-1)Marketed from Sep 28, 2023 | |
| 70518-3883-2 | 70518388302 | 30 TABLET in 1 BLISTER PACK (70518-3883-2)Marketed from Jan 22, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077493
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3883_53e72de3-fe1e-f5a0-e063-6294a90a997cSPL ID 53e72de3-fe1e-f5a0-e063-6294a90a997cSPL set ID c84807bd-35d7-4138-8989-42617d69293aRxCUI 312830UNII 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
N470518388300followed by a unit qualifier and the quantityPackage 70518-3883-00. 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 077493
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 .25 mg/1 | TabletOral | Coupler LLC | 67046-2064 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2645 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3873 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8196 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8198 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8288 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8197 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8265 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-259 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-339 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-340 |
| Risperidone | Risperidone 4 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-344 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-341 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-342 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-343 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4426 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4431 |