Sitavig
NDC Package 71403-049-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sitavig is a medication used to treat cold sores around the mouth (caused by herpes virus) that keep coming back. Marketed by Epi Health, Inc, this product is identified by NDC 71403-049 and is authorized under FDA application NDA203791.

Identification & Billing

NDC Package Code
71403-049-02
Package Description
1 BLISTER PACK in 1 CARTON / 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
71403-049
11-Digit Billing Format
71403004902
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sitavig
Dosage Form
-
Usage Information
This medication is used to treat cold sores around the mouth (caused by herpes virus) that keep coming back. Acyclovir is an antiviral drug. However, it is not a cure for the infection. The virus that causes infection continues to live in the body between outbreaks. Acyclovir makes outbreaks shorter and less severe. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain lasts after the sores heal.

Regulatory & Marketing

Labeler Name
Epi Health, Inc
FDA Application #
NDA203791
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-20-2014
Listing Expiration
12-31-2023
Exclude Flag
I
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 71403-049-02 identifies a specific commercial package of 1 blister pack in 1 carton / 2 tablet, delayed release in 1 blister pack of Sitavig, labeled by Epi Health, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Epi Health, Inc on March 20, 2014. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

This medication is used to treat cold sores around the mouth (caused by herpes virus) that keep coming back. Acyclovir is an antiviral drug. However, it is not a cure for the infection. The virus that causes infection continues to live in the body between outbreaks. Acyclovir makes outbreaks shorter and less severe. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain lasts after the sores heal.

How is this Epi Health, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71403004902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
71403-049-02
11-Digit CMS (5-4-2)
71403-0049-02

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