Prescription drug · ANDA
Risperidone NDC 68071-4618
Risperidone 2 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4618-3 | 68071461803 | 30 TABLET in 1 BOTTLE (68071-4618-3)Marketed from Oct 29, 2018 |
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
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201003
- Marketing start
- Listing expires
- Identifiers
- Product ID 68071-4618_1ab66f0e-a2a8-09b0-e063-6394a90aec7bSPL ID 1ab66f0e-a2a8-09b0-e063-6394a90aec7bSPL set ID 79648a52-1364-c25b-e053-2a91aa0a8ea4RxCUI 312831UNII L6UH7ZF8HCUPC 0368071461831
- 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
N468071461803followed by a unit qualifier and the quantityPackage 68071-4618-03. 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 tablets are 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 tablets are 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 tablets are indicated for the treatment of acute ma…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201003
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 .5 mg/1 | TabletOral | Proficient Rx LP | 63187-642 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Proficient Rx LP | 63187-264 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-908 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-3341 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-3340 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0459 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3344 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Coupler LLC | 67046-0630 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Coupler LLC | 67046-0635 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | Coupler LLC | 67046-0644 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Proficient Rx LP | 63187-439 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0626 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | Direct_Rx | 72189-525 |
| Risperidone | Risperidone 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-246 |
| Risperidone | Risperidone 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1502 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-264 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1575 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0130 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0740 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1568 |
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