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  4. NDC Product Code: 68258-8912 Havrix

NDC 68258-8912 Havrix

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68258-8912?
  4. Havrix Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
68258-8912
Proprietary Name:
Havrix
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Dispensing Solutions, Inc.
Labeler Code:
68258
Product Label ID:
135ff1b4-c21f-4df1-97be-9475680e9e44
Start Marketing Date: [9]
04-13-2007
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Code Structure Chart

Product Details

What is NDC 68258-8912?

The NDC code 68258-8912 is assigned by the FDA to the product Havrix which is product labeled by Dispensing Solutions, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68258-8912-9 1 ml in 1 vial . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Havrix?

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.

Which are Havrix UNII Codes?

The UNII codes for the active ingredients in this product are:

  • HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ)
  • HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ) (Active Moiety)

Which are Havrix Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Havrix?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".