Prescription drug · ANDA
Risperidone NDC 0615-8198
Risperidone 1 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8198-05 | 00615819805 | 15 TABLET in 1 BLISTER PACK (0615-8198-05)Marketed from Feb 6, 2018 | |
| 0615-8198-39 | 00615819839 | 30 TABLET in 1 BLISTER PACK (0615-8198-39)Marketed from Feb 6, 2018 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077493
- Marketing start
- Listing expires
- Identifiers
- Product ID 0615-8198_102140c8-c00e-4498-8e1a-322d5de68198SPL ID 102140c8-c00e-4498-8e1a-322d5de68198SPL set ID 7bbc37f1-6d6a-4021-8976-1f103ce1cfbdRxCUI 312828, 312829, 312830, 312831, 312832UNII 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
N400615819805followed by a unit qualifier and the quantityPackage 00615-8198-05. 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 episodes as…
Excerpt only. Read the full label for complete information.
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 | REMEDYREPACK INC. | 70518-3883 |
| 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 |