Zovirax
NDC Package 0378-9735-73

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Zovirax is a medication used to treat "cold sores/fever blisters" (herpes labialis). Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-9735 and is authorized under FDA application NDA019909.

Identification & Billing

NDC Package Code
0378-9735-73
Package Description
473 mL in 1 BOTTLE
Product Code
0378-9735
11-Digit Billing Format
00378973573
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

Clinical Specifications

Proprietary Name
Zovirax
Dosage Form
-
Usage Information
This medication is used to treat "cold sores/fever blisters" (herpes labialis). It can speed up healing of the sores and decrease symptoms (such as tingling, pain, burning, itching). Acyclovir belongs to a class of medications known as antivirals. It works by stopping the growth of the virus. This medication does not cure herpes, and it does not prevent passing the infection to someone else. It does not prevent a future occurrence.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
FDA Application #
NDA019909
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-05-2018
End Marketing Date
02-28-2023
Listing Expiration
02-28-2023
Exclude Flag
D
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J8499
Source: PDAC
PRESCRIPTION DRUG, ORAL, NON CHEMOTHERAPEUTIC, NOS
HCPCS Dosage 1 EA
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0378-9735-73 identifies a specific commercial package of 473 ml in 1 bottle of Zovirax, labeled by Mylan Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on October 05, 2018. The current certification is valid through February 28, 2023.

What are the primary indications for this medication?

This medication is used to treat "cold sores/fever blisters" (herpes labialis). It can speed up healing of the sores and decrease symptoms (such as tingling, pain, burning, itching). Acyclovir belongs to a class of medications known as antivirals. It works by stopping the growth of the virus. This medication does not cure herpes, and it does not prevent passing the infection to someone else. It does not prevent a future occurrence.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378973573. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (4-4-2)
0378-9735-73
11-Digit CMS (5-4-2)
00378-9735-73

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