Ribasphere
NDC Package 66435-101-18
Package Information
Ribasphere is ribavirin is used in combination with other antiviral medications (such as interferon, sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Marketed by Kadmon Pharmaceuticals, Llc, this product is identified by NDC 66435-101 and is authorized under FDA application ANDA076203.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 66435 - Kadmon Pharmaceuticals, Llc
- 66435-101 - Ribasphere
- 66435-101-18 - 180 CAPSULE in 1 BOTTLE, PLASTIC
- 66435-101 - Ribasphere
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 (66435-101). 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 66435-101-18 identifies a specific commercial package of 180 capsule in 1 bottle, plastic of Ribasphere, labeled by Kadmon Pharmaceuticals, Llc. 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 Kadmon Pharmaceuticals, Llc on April 07, 2004. The current certification is valid through September 30, 2019.
What are the primary indications for this medication?
Ribavirin is used in combination with other antiviral medications (such as interferon, sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. Ribavirin works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
How is this Kadmon Pharmaceuticals, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 66435010118. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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.
