Ribavirin Powder, For Solution
NDC Package 68475-003-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ribavirin powders 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. This formulation utilizes a powder, for solution delivery system. Marketed by Navinta Llc, this product is identified by NDC 68475-003 and is authorized under FDA application ANDA207366.

Identification & Billing

NDC Package Code
68475-003-04
Package Description
4 VIAL in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 VIAL
Product Code
68475-003
11-Digit Billing Format
68475000304
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ribavirin
Non-Proprietary Name
Ribavirin
Substance Name
Ribavirin
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
RIBAVIRIN 6 g/1
Pharmacologic Class
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
Navinta Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207366
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2020
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68475-003-04 identifies a specific commercial package of 4 vial in 1 carton / 1 powder, for solution in 1 vial of Ribavirin, a human prescription drug labeled by Navinta Llc. This powder, for solution is formulated for respiratory (inhalation) use and contains ribavirin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Navinta Llc on April 21, 2020. The current certification is valid through December 31, 2026.

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 Navinta Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68475000304. 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 (5-3-2)
68475-003-04
11-Digit CMS (5-4-2)
68475-0003-04

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