Valacyclovir Tablet
NDC Package 72189-630-30

11-digit billing NDC: 72189063030 · Billing unit: EA · 20 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Valacyclovir tablets is 1.1 Adult PatientsCold Sores (Herpes Labialis)Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). This formulation utilizes a tablet delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-630 and is authorized under FDA application ANDA209553.

Identification & Billing

NDC Package Code
72189-630-30
Package Description
20 TABLET in 1 BOTTLE
Product Code
72189-630
11-Digit Billing Format
72189063030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
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 500 mg/1
Pharmacologic Class
Usage Information
1.1 Adult PatientsCold Sores (Herpes Labialis)Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.Genital HerpesInitial Episode: Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established.Recurrent Episodes: Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established.Suppressive Therapy: Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1-infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1-infected patients have not been established.Reduction of Transmission: Valacyclovir tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines).Herpes ZosterValacyclovir tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults.The efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established.1.2 Pediatric PatientsCold Sores (Herpes Labialis)Valacyclovir tablets are indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.ChickenpoxValacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash [see Clinical Studies (14.4)].1.3 Limitations of UseThe efficacy and safety of valacyclovir tablets have not been established in:Immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm3. Patients aged less than 12 years with cold sores (herpes labialis). Patients aged less than 2 years or greater than or equal to 18 years with chickenpox. Patients aged less than 18 years with genital herpes. Patients aged less than 18 years with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA209553
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72189-630). Click a package code to view its specific billing and regulatory data.

72189-630-20
20 TABLET in 1 BOTTLE

* 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 72189-630-30 identifies a specific commercial package of 20 tablet in 1 bottle of Valacyclovir, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package. 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 Direct_rx on June 26, 2025. The current certification is valid through December 31, 2026.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189063030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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)
72189-630-30
11-Digit CMS (5-4-2)
72189-0630-30

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