NDC 0006-4309 Sterile Diluent

Sterile Water Injection Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0006-4309
Proprietary Name:
Sterile Diluent
Non-Proprietary Name: [1]
Sterile Water
Substance Name: [2]
Water
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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
    FDA Application Number: [6]
    BLA125123
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    05-25-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0006-4309-00

    Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON / .7 mL in 1 VIAL, SINGLE-DOSE (0006-4309-01)

    Product Details

    What is NDC 0006-4309?

    The NDC code 0006-4309 is assigned by the FDA to the product Sterile Diluent which is a vaccine label product labeled by Merck Sharp & Dohme Llc. The generic name of Sterile Diluent is sterile water. The product's dosage form is injection and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0006-4309-00 10 vial, single-dose in 1 carton / .7 ml in 1 vial, single-dose (0006-4309-01). 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 Sterile Diluent?

    Hypersensitivity to any component of the vaccine, including gelatin.{40}Do not give M-M-R II to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and PRECAUTIONS, Pregnancy).Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).Febrile respiratory illness or other active febrile infection. However, the ACIP has recommended that all vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.{41}Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses;{41-43} cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis{44} (MIBE), pneumonitis{45} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

    What are Sterile Diluent 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.
    • WATER .7 mL/.7mL - A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

    What is the NDC to RxNorm Crosswalk for Sterile Diluent?

    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: 804183 - measles, mumps, and rubella virus vaccine live (generic for M-M-R II) 0.5 ML Injection
    • RxCUI: 804183 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 25000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML Injection
    • RxCUI: 804186 - M-M-R II vaccine 0.5 ML Injection
    • RxCUI: 804186 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 25000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML Injection [M-M-R II]
    • RxCUI: 804186 - M-M-R II, Measles, Mumps, and Rubella Virus Vaccine Live 0.5 ML Injection

    * 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".