Valacyclovir
NDC Package 70518-0323-0

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 discontinued by the firm.

Valacyclovir is used to treat infections caused by certain types of viruses. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-0323 and is authorized under FDA application ANDA076588.

Identification & Billing

NDC Package Code
70518-0323-0
Package Description
4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
70518-0323
11-Digit Billing Format
70518032300

Clinical Specifications

Proprietary Name
Valacyclovir
Dosage Form
-
Usage Information
Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth. Valacyclovir is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, this medication is used to reduce the number of future episodes. Valacyclovir is an antiviral drug. It stops the growth of certain viruses. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Valacyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA076588
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-16-2017
End Marketing Date
03-17-2018
Listing Expiration
03-17-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-0323-0 identifies a specific commercial package of 4 tablet, film coated in 1 bottle, plastic of Valacyclovir, labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on March 16, 2017. The current certification is valid through March 17, 2018.

What are the primary indications for this medication?

Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth. Valacyclovir is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, this medication is used to reduce the number of future episodes. Valacyclovir is an antiviral drug. It stops the growth of certain viruses. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Valacyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518032300. 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)
70518-0323-0
11-Digit CMS (5-4-2)
70518-0323-00

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