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  5. NDC Package Code: 68084-309-21 Valacyclovir Hydrochloride

NDC Package 68084-309-21 Valacyclovir Hydrochloride

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
68084-309-21
Package Description:
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-309-11)
Product Code:
68084-309
Proprietary Name:
Valacyclovir Hydrochloride
Non-Proprietary Name:
Valacyclovir Hydrochloride
Substance Name:
Valacyclovir Hydrochloride
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)] .
11-Digit NDC Billing Format:
68084030921
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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
  • RxCUI: 313565 - valACYclovir 500 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    American Health Packaging
    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):
  • VALACYCLOVIR HYDROCHLORIDE 1 g/1
    • Pharmacologic Class(es):
  • DNA Polymerase Inhibitors - [MoA] (Mechanism of Action)
  • Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Nucleoside Analog - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    ANDA090682
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-19-2014
    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.

    Frequently Asked Questions

    What is NDC 68084-309-21?

    The NDC Packaged Code 68084-309-21 is assigned to a package of 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (68084-309-11) of Valacyclovir Hydrochloride, a human prescription drug labeled by American Health Packaging. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 68084-309 included in the NDC Directory?

    Yes, Valacyclovir Hydrochloride with product code 68084-309 is active and included in the NDC Directory. The product was first marketed by American Health Packaging on February 19, 2014 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 NDC billing unit for package 68084-309-21?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 68084-309-21?

    The 11-digit format is 68084030921. 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 5-3-2 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
    5-3-268084-309-215-4-268084-0309-21