Prescription drug · ANDA
Risperidone NDC 59746-010
Risperidone .5 mg/1 · Tablet, Orally disintegrating · Oral · Jubilant Cadista Pharmacuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-010-22 | 59746001022 | 7 BLISTER PACK in 1 CARTON (59746-010-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 4, 2011 | |
| 59746-010-32 | 59746001032 | 3 BLISTER PACK in 1 CARTON (59746-010-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 4, 2011 |
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 — .5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090839
- Marketing start
- Listing expires
- Identifiers
- Product ID 59746-010_90b80768-87f7-4fb1-8142-909dba9555e2SPL ID 90b80768-87f7-4fb1-8142-909dba9555e2SPL set ID 739dcf8a-ed73-5eb0-899b-7e51cb73c335RxCUI 401953, 401954, 403825, 616698, 616705UNII L6UH7ZF8HCUPC 0359746020224, 0359746030223, 0359746010324, 0359746040222, 0359746050221
- 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
N459746001022followed by a unit qualifier and the quantityPackage 59746-0010-22. 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 orally disintegrating 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 orally disintegrating 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 orally d…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090839
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, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-040 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-020 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-030 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-050 |