Valacyclovir Tablet
NDC Package 70518-4100-2

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

Package Information

Valacyclovir tablets is valacyclovir is used to treat infections caused by certain types of viruses. This formulation utilizes a tablet delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4100 and is authorized under FDA application ANDA209553.

Identification & Billing

NDC Package Code
70518-4100-2
Package Description
14 TABLET in 1 BOTTLE, PLASTIC
Product Code
70518-4100
11-Digit Billing Format
70518410002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valacyclovir
Non-Proprietary Name
Valacyclovir
Substance Name
Valacyclovir Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALACYCLOVIR HYDROCHLORIDE 1000 mg/1
Pharmacologic Class
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.
Product Type
Human Prescription Drug
FDA Application #
ANDA209553
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2024
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-4100). Click a package code to view its specific billing and regulatory data.

70518-4100-0
30 TABLET in 1 BOTTLE, PLASTIC
70518-4100-1
21 TABLET in 1 BOTTLE, PLASTIC
70518-4100-3
7 TABLET in 1 BOTTLE, PLASTIC
70518-4100-4
4 TABLET in 1 BOTTLE, PLASTIC
70518-4100-5
10 TABLET in 1 BOTTLE, PLASTIC
70518-4100-6
20 TABLET 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 70518-4100-2 identifies a specific commercial package of 14 tablet in 1 bottle, plastic of Valacyclovir, a human prescription drug labeled by Remedyrepack Inc.. This tablet is formulated for oral use and contains valacyclovir hydrochloride 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 Remedyrepack Inc. on June 12, 2024. The current certification is valid through December 31, 2027.

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: 70518410002. 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)
70518-4100-2
11-Digit CMS (5-4-2)
70518-4100-02

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