Valacyclovir Hydrochloride Tablet, Film Coated
NDC Package 71335-0708-2

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 Hydrochloride tablets is valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-0708 and is authorized under FDA application ANDA090682.

Identification & Billing

NDC Package Code
71335-0708-2
Package Description
10 TABLET, FILM COATED in 1 BOTTLE
Product Code
71335-0708
11-Digit Billing Format
71335070802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valacyclovir Hydrochloride
Non-Proprietary Name
Valacyclovir Hydrochloride
Substance Name
Valacyclovir Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALACYCLOVIR HYDROCHLORIDE 500 mg/1
Pharmacologic Class
Usage Information
Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA090682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-24-2010
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 (71335-0708). Click a package code to view its specific billing and regulatory data.

71335-0708-0
60 TABLET, FILM COATED in 1 BOTTLE
71335-0708-1
15 TABLET, FILM COATED in 1 BOTTLE
71335-0708-3
4 TABLET, FILM COATED in 1 BOTTLE
71335-0708-4
7 TABLET, FILM COATED in 1 BOTTLE
71335-0708-5
20 TABLET, FILM COATED in 1 BOTTLE
71335-0708-6
30 TABLET, FILM COATED in 1 BOTTLE
71335-0708-7
8 TABLET, FILM COATED in 1 BOTTLE
71335-0708-8
90 TABLET, FILM COATED in 1 BOTTLE
71335-0708-9
14 TABLET, FILM COATED 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 71335-0708-2 identifies a specific commercial package of 10 tablet, film coated in 1 bottle of Valacyclovir Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. This tablet, film coated 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 Bryant Ranch Prepack on May 24, 2010. The current certification is valid through December 31, 2027.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335070802. 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)
71335-0708-2
11-Digit CMS (5-4-2)
71335-0708-02

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