Proquad Injection, Powder, Lyophilized, For Suspension
NDC 0006-4171

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0006-4171?
  5. Proquad 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

Proquad (measles, mumps, rubella and varicella virus vaccine live) is a BLA-approved product labeled by Merck Sharp & Dohme Llc. This medication is a combination of vaccines against several virus infections: measles (also known as rubeola), mumps, rubella (also known as German measles), and varicella (also known as chickenpox). It is supplied as a yellow injection, powder, lyophilized, for suspension for intramuscular; subcutaneous administration. This product entry covers the primary NDC 0006-4171 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0006-4171
Proprietary Name:
Proquad
Non-Proprietary Name: [1]
Measles, Mumps, Rubella And Varicella Virus Vaccine Live
Substance Name: [2]
Measles Virus Strain Enders' Attenuated Edmonston Live Antigen; Mumps Virus Strain B Level Jeryl Lynn Live Antigen; Rubella Virus Strain Wistar Ra 27/3 Live Antigen; 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]
  • Intramuscular - Administration within a muscle.
  • 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:
73eae9fc-507b-4c9c-883d-63eb2e3cc6f6
FDA Application Number: [6]
BLA125108
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
07-01-2015
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330)
PINK (C48328 - CLEAR PALE YELLOW TO LIGHT PINK)

Code Structure Chart

Product Details

What is NDC 0006-4171?

The NDC code 0006-4171 is assigned by the FDA to the product Proquad. It is commonly known by its generic name, measles, mumps, rubella and 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 intramuscular; subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-4171-00. 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?

This medication is a combination of vaccines against several virus infections: measles (also known as rubeola), mumps, rubella (also known as German measles), and varicella (also known as chickenpox). These are common childhood infections that may cause serious (rarely fatal) problems. Vaccination is the best way to protect against these infections. Vaccines work by causing the body to produce its own protection (antibodies). This combination of vaccines is usually used in children between 12 months and 12 years old.

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:

  • MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN (UNII: MFZ8I7277D)
  • MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN (UNII: MFZ8I7277D) (Active Moiety)
  • MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (UNII: 47QB6MX9KU)
  • MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (UNII: 47QB6MX9KU) (Active Moiety)
  • RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z)
  • RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z) (Active Moiety)
  • 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: 1292440 - measles, mumps, rubella and varicella virus vaccine live (MMRV) 0.5 ML Injection
  • RxCUI: 1292440 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 40000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML / varicella-zoster virus vaccine live (Oka-Merck) strain 20000 UNT/ML Injection
  • RxCUI: 1292440 - measles, mumps, rubella and varicella virus vaccine live 0.5 ML Injection
  • RxCUI: 1292443 - ProQuad vaccine 0.5 ML Injection
  • RxCUI: 1292443 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 40000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML / varicella-zoster virus vaccine live (Oka-Merck) strain 20000 UNT/ML Injection [ProQuad]

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.

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Patient Education

MMR Vaccine (Measles, Mumps, and Rubella)


Why get vaccinated? MMR vaccine can prevent measles, mumps, and rubella. Measles (M)causes fever, cough, runny nose, and red, watery eyes, commonly followed by a rash that covers the whole body. It can lead to seizures (often associated with fever), ear infections, diarrhea, and pneumonia. Rarely, measles can cause brain damage or death. Mumps (M) causes fever, headache, muscle aches, tiredness, loss of appetite, and swollen and tender glands under the ears. It can lead to deafness, swelling of the brain and/or spinal cord covering, painful swelling of the testicles or ovaries, and, very rarely, death. Rubella (R) causes fever, sore throat, rash, headache, and eye irritation. It can cause arthritis in up to half of teenage and adult women. If a person gets rubella while they ares pregnant, they could have a miscarriage or the baby could be born with serious birth defects. Most people who are vaccinated with MMR will be protected for life. Vaccines and high rates of vaccination have made these diseases much less common in the United States.
[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".