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NDC 0006-4171 Proquad

Measles,Mumps,Rubella And Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For - View Dosage, Usage, Ingredients, Routes, UNII

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

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
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 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.
    Start Marketing Date: [9]
    07-01-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

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

    Product Packages

    NDC Code 0006-4171-00

    Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4171-01)

    Product Details

    What is NDC 0006-4171?

    The NDC code 0006-4171 is assigned by the FDA to the product Proquad which is a vaccine label product labeled by Merck Sharp & Dohme Llc. The generic name of Proquad is measles, mumps, rubella and varicella virus vaccine live. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0006-4171-00 10 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (0006-4171-01). 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 Proquad?

    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 Proquad Active Ingredients?

    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 Proquad 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 Proquad 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 Proquad?

    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 for Proquad?

    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 disclaimer below.

    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 disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [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".