Prescription drug · ANDA
Risperidone NDC 71335-2645
Risperidone 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2645-1 | 71335264501 | 60 TABLET in 1 BOTTLE (71335-2645-1)Marketed from Jun 3, 2025 | |
| 71335-2645-2 | 71335264502 | 30 TABLET in 1 BOTTLE (71335-2645-2)Marketed from Jun 3, 2025 | |
| 71335-2645-3 | 71335264503 | 90 TABLET in 1 BOTTLE (71335-2645-3)Marketed from Jun 3, 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077493
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2645_e568a5f6-8644-497b-9893-f84bd2486225SPL ID e568a5f6-8644-497b-9893-f84bd2486225SPL set ID 684dcda4-d270-400c-9798-7d920a038bbbRxCUI 312831UNII 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
N471335264501followed by a unit qualifier and the quantityPackage 71335-2645-01. 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 . 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 episo…
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 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 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 |