Havrix
NDC Package 68258-8912-9

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Havrix is this vaccine is used to help prevent infection from the hepatitis A virus. Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-8912 and is authorized under FDA application BLA103475.

Identification & Billing

NDC Package Code
68258-8912-9
Package Description
1 mL in 1 VIAL
Product Code
68258-8912
11-Digit Billing Format
68258891209
RxNorm Crosswalk
  • RxCUI: 1658058 - hepatitis A vaccine adult (HepA) 1440 UNT in 1 ML Injection
  • RxCUI: 1658058 - 1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection
  • RxCUI: 1658060 - HAVRIX adult vaccine 1440 UNT in 1 ML Injection
  • RxCUI: 1658060 - 1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]
  • RxCUI: 1658060 - 1 ML Havrix 1440 UNT/ML Injection

Clinical Specifications

Proprietary Name
Havrix
Dosage Form
-
Usage Information
This vaccine is used to help prevent infection from the hepatitis A virus. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Preventing infection can prevent these problems. Hepatitis A vaccine is made from whole, killed hepatitis A virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A virus. Hepatitis A vaccine does not protect you from other virus infections (such as HIV virus, which causes AIDS; hepatitis B, hepatitis C or hepatitis E; HPV virus, which causes genital warts and other problems). The vaccine is recommended for people aged 12 months and older, especially those at an increased risk of getting the infection. Those at an increased risk include people who live with or spend much time with people with hepatitis A infections, institutional or daycare workers, lab workers, people with multiple sex partners, men who have sex with men, sex workers, injecting and non-injecting drug abusers, and people traveling to high-risk areas.

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
BLA103475
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-13-2007
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68258-8912-9 identifies a specific commercial package of 1 ml in 1 vial of Havrix, labeled by Dispensing Solutions, Inc.. 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 Dispensing Solutions, Inc. on April 13, 2007. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This vaccine is used to help prevent infection from the hepatitis A virus. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Preventing infection can prevent these problems. Hepatitis A vaccine is made from whole, killed hepatitis A virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A virus. Hepatitis A vaccine does not protect you from other virus infections (such as HIV virus, which causes AIDS; hepatitis B, hepatitis C or hepatitis E; HPV virus, which causes genital warts and other problems). The vaccine is recommended for people aged 12 months and older, especially those at an increased risk of getting the infection. Those at an increased risk include people who live with or spend much time with people with hepatitis A infections, institutional or daycare workers, lab workers, people with multiple sex partners, men who have sex with men, sex workers, injecting and non-injecting drug abusers, and people traveling to high-risk areas.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258891209. 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)
68258-8912-9
11-Digit CMS (5-4-2)
68258-8912-09

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