Sterile Diluent Injection
NDC 0006-4175
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Sterile Diluent (sterile water) is a BLA-approved product labeled by Merck Sharp & Dohme Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection for intramuscular; subcutaneous administration. This product entry covers the primary NDC 0006-4175 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0006-4175
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
Code Navigator:
Clinical Specifications
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]
- Intramuscular - Administration within a muscle.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0006
Product Label ID:
FDA Application Number: [6]
BLA101069
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
08-21-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0006-4175?
The NDC code 0006-4175 is assigned by the FDA to the product Sterile Diluent. It is commonly known by its generic name, sterile water. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a injection administered via intramuscular; subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-4175-88. 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?
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 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.
- 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 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: 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
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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".
