NDC Package 53002-0060-1 Valacyclovir Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53002-0060-1
Package Description:
2 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Valacyclovir Hydrochloride
Non-Proprietary Name:
Valacyclovir Hydrochloride
Substance Name:
Valacyclovir Hydrochloride
Usage Information:
Valacyclovir hydrochloride is 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)].
11-Digit NDC Billing Format:
53002006001
NDC to RxNorm Crosswalk:
  • RxCUI: 313564 - valACYclovir 1 GM Oral Tablet
  • RxCUI: 313564 - valacyclovir 1000 MG Oral Tablet
  • RxCUI: 313564 - valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet
  • RxCUI: 313564 - valacyclovir 1 GM Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA201506
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-05-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53002-0060-030 TABLET, FILM COATED in 1 BOTTLE
    53002-0060-24 TABLET, FILM COATED in 1 BOTTLE
    53002-0060-310 TABLET, FILM COATED in 1 BOTTLE
    53002-0060-414 TABLET, FILM COATED in 1 BOTTLE
    53002-0060-520 TABLET, FILM COATED in 1 BOTTLE
    53002-0060-621 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-0060-1?

    The NDC Packaged Code 53002-0060-1 is assigned to a package of 2 tablet, film coated in 1 bottle of Valacyclovir Hydrochloride, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 53002-0060 included in the NDC Directory?

    Yes, Valacyclovir Hydrochloride with product code 53002-0060 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on April 05, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-0060-1?

    The 11-digit format is 53002006001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-153002-0060-15-4-253002-0060-01