Ribavirin
NDC Package 54868-4521-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 Physicians Total Care, Inc., this product is identified by NDC 54868-4521 and is authorized under FDA application ANDA076203.

Identification & Billing

NDC Package Code
54868-4521-0
Package Description
70 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
54868452100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
70 EA

Clinical Specifications

Proprietary Name
Ribavirin
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076203
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2005
End Marketing Date
06-30-2011
Listing Expiration
06-30-2011
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 (54868-4521). Click a package code to view its specific billing and regulatory data.

42 CAPSULE in 1 BOTTLE, PLASTIC
168 CAPSULE in 1 BOTTLE, PLASTIC
180 CAPSULE in 1 BOTTLE, PLASTIC

* 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 54868-4521-0 identifies a specific commercial package of 70 capsule in 1 bottle, plastic of Ribavirin, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 70 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 Physicians Total Care, Inc. on November 01, 2005. The current certification is valid through June 30, 2011.

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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868452100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 70 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:

10-Digit Format (5-4-1)
54868-4521-0
11-Digit CMS (5-4-2)
54868-4521-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.