Varivax Injection, Powder, Lyophilized, For Suspension
NDC 0006-4827

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0006-4827?
  5. Varivax Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Varivax (varicella virus vaccine live) is a BLA-approved product labeled by Merck Sharp & Dohme Llc. This medication is typically used as a actively acquired immunity [pe]. It is supplied as a yellow injection, powder, lyophilized, for suspension for subcutaneous administration. This product entry covers the primary NDC 0006-4827 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0006-4827
Proprietary Name:
Varivax
Non-Proprietary Name: [1]
Varicella Virus Vaccine Live
Substance Name: [2]
Varicella-zoster Virus Strain Oka/merck Live Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Merck Sharp & Dohme Llc
Labeler Code:
0006
Product Label ID:
524cf052-e90e-4595-af0a-608edbe9bd31
FDA Application Number: [6]
BLA103552
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
03-17-1995
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - CLEAR, COLORLESS TO PALE YELLOW)

Code Structure Chart

Product Details

What is NDC 0006-4827?

The NDC code 0006-4827 is assigned by the FDA to the product Varivax. It is commonly known by its generic name, varicella virus vaccine live. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a injection, powder, lyophilized, for suspension administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-4827-00. 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?

VARIVAX® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

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

  • VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (UNII: GPV39ZGD8C)
  • VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (UNII: GPV39ZGD8C) (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: 1292457 - varicella virus vaccine live (VAR) 1350 PFU in 0.5 ML Injection
  • RxCUI: 1292457 - 0.5 ML varicella-zoster virus vaccine live (Oka-Merck) strain 2700 UNT/ML Injection
  • RxCUI: 1292457 - varicella-zoster virus vaccine live (Oka-Merck) strain 1350 PFU per 0.5 ML Injection
  • RxCUI: 1292459 - VARIVAX vaccine 0.5 ML Injection
  • RxCUI: 1292459 - 0.5 ML varicella-zoster virus vaccine live (Oka-Merck) strain 2700 UNT/ML Injection [Varivax]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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

Patient Education

Live Shingles (Zoster) Vaccine (ZVL)


Why get vaccinated? Live 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.
[Learn More]


Varicella (Chickenpox) Vaccine


Why get vaccinated? Varicella vaccine can prevent varicella. Varicella, also called "chickenpox," causes an itchy rash that usually lasts about a week. It can also cause fever, tiredness, loss of appetite, and headache. It can lead to skin infections, pneumonia, inflammation of the blood vessels, swelling of the brain and/or spinal cord covering, and infections of the bloodstream, bone, or joints. Some people who get chickenpox get a painful rash called "shingles" (also known as herpes zoster) years later. Chickenpox is usually mild, but it can be serious in infants under 12 months of age, adolescents, adults, pregnant people, and people with a weakened immune system. Some people get so sick that they need to be hospitalized. It doesn't happen often, but people can die from chickenpox. Most people who are vaccinated with 2 doses of varicella vaccine will be protected for life.
[Learn More]


* 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 is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".