Havrix
NDC 68258-8912
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Havrix is a BLA-approved product labeled by Dispensing Solutions, Inc.. This vaccine is used to help prevent infection from the hepatitis A virus. It is supplied as a product. This product entry covers the primary NDC 68258-8912 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68258-8912
Proprietary Name:
Havrix
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
68258
Product Label ID:
FDA Application Number: [6]
BLA103475
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
04-13-2007
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 68258-8912?
The NDC code 68258-8912 is assigned by the FDA to the product Havrix. This pharmaceutical product is labeled by Dispensing Solutions, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68258-8912-9. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 the associated 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 the Inactive Ingredients associated 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:
- ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
- POLYSORBATE 20 (UNII: 7T1F30V5YH)
What is the NDC to RxNorm Crosswalk for this product?
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
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
