Shingrix Kit
NDC 58160-823

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58160-823?
  4. Shingrix Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Shingrix (zoster vaccine recombinant, adjuvanted) is a BLA-approved product labeled by Glaxosmithkline Biologicals Sa. This vaccine is used by adults 50 years and older to prevent zoster (shingles). It is supplied as a kit. This product entry covers the primary NDC 58160-823 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58160-823
Proprietary Name:
Shingrix
Non-Proprietary Name: [1]
Zoster Vaccine Recombinant, Adjuvanted
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Glaxosmithkline Biologicals Sa
Labeler Code:
58160
Product Label ID:
0280849d-5c78-4a9d-8941-4eab429f6bd8
FDA Application Number: [6]
BLA125614
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
10-20-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58160-823?

The NDC code 58160-823 is assigned by the FDA to the product Shingrix. It is commonly known by its generic name, zoster vaccine recombinant, adjuvanted. This pharmaceutical product is labeled by Glaxosmithkline Biologicals Sa and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58160-823-11. 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 by adults 50 years and older to prevent zoster (shingles). Zoster is caused by the same virus that causes chickenpox. After you have been infected with chickenpox (usually in childhood), the virus can live in your body's nerve roots in an inactive form. For reasons that are not fully understood, the virus may become active again. This causes shingles with symptoms of rash, blisters, and pain. This vaccine works by boosting the body's natural defense (immunity) against the zoster virus so that symptoms of shingles do not develop. It should not be used for treating active shingles, nerve pain caused by shingles, or for the prevention of chickenpox. Vaccines may not fully protect everyone who receives them. This vaccine should not be used by children.

Which are the associated UNII Codes?

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

  • GE: RECOMBINANT VARICELLA ZOSTER VIRUS (VZV) GLYCOPROTEIN E (UNII: COB9FF6I46)
  • GE: RECOMBINANT VARICELLA ZOSTER VIRUS (VZV) GLYCOPROTEIN E (UNII: COB9FF6I46) (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:

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: 1986825 - varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL Injection
  • RxCUI: 1986825 - 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection
  • RxCUI: 1986825 - 0.5 ML zoster vaccine, recombinant 0.1 MG/ML
  • RxCUI: 1986830 - SHINGRIX vaccine 0.5 ML Injection
  • RxCUI: 1986830 - 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix]

* Please review the full disclaimer at the bottom of this page.

Patient Education

Recombinant Zoster (Shingles) Vaccine (RZV)


Why get vaccinated? Recombinant zoster (shingles) vaccine can prevent shingles. Shingles (also called herpes zoster, or just zoster) is a painful skin rash, usually with blisters. In addition to the rash, shingles can cause fever, headache, chills, or upset stomach. More rarely, shingles can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis), or death. The most common complication of shingles is long-term nerve pain called postherpetic neuralgia (PHN). PHN occurs in the areas where the shingles rash was, even after the rash clears up. It can last for months or years after the rash goes away. The pain from PHN can be severe and debilitating. About 10 to 18% of people who get shingles will experience PHN. The risk of PHN increases with age. An older adult with shingles is more likely to develop PHN and have longer lasting and more severe pain than a younger person with shingles. Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. After you have chickenpox, the virus stays in your body and can cause shingles later in life. Shingles cannot be passed from one person to another, but the virus that causes shingles can spread and cause chickenpox in someone who had never had chickenpox or received chickenpox vaccine.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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".