Prescription drug · ANDA
Risperidone NDC 83745-186
Risperidone 1 mg/mL · Solution · Oral · APOZEAL PHARMACEUTICALS INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83745-186-30 | 83745018630 | 30 mL in 1 BOTTLE (83745-186-30)Marketed from Jan 31, 2025 |
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 — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- APOZEAL PHARMACEUTICALS INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078909
- Marketing start
- Listing expires
- Identifiers
- Product ID 83745-186_38eb3e14-7f79-42c8-ac58-2c050c6295a8SPL ID 38eb3e14-7f79-42c8-ac58-2c050c6295a8SPL set ID 4ab6d256-6590-45be-a5df-f505987f96c3RxCUI 199387UNII 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
N483745018630followed by a unit qualifier and the quantityPackage 83745-0186-30. 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 agent 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 oral solution 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 oral solution is indicated for the treatment of…
Excerpt only. Read the full label for complete information.