Risperidone
NDC Package 43353-754-45
Package Information
Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-754 and is authorized under FDA application ANDA076288.
Identification & Billing
- RxCUI: 312830 - risperiDONE 1 MG Oral Tablet
- RxCUI: 312830 - risperidone 1 MG Oral Tablet
- RxCUI: 312831 - risperiDONE 2 MG Oral Tablet
- RxCUI: 312831 - risperidone 2 MG Oral Tablet
- RxCUI: 312832 - risperiDONE 3 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43353 - Aphena Pharma Solutions - Tennessee, Llc
- 43353-754 - Risperidone
- 43353-754-45 - 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 43353-754 - Risperidone
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (43353-754). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 43353-754-45 identifies a specific commercial package of 45 tablet, film coated in 1 bottle, plastic of Risperidone, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 45 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on September 17, 2008. The current certification is valid through December 31, 2019.
What are the primary indications for this medication?
Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life. Risperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.
How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353075445. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 45 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
