NDC 65044-9942 Yellow Hornet Hymenoptera Venom Multidose

Injection, Powder, Lyophilized, For Solution Percutaneous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
65044-9942
Proprietary Name:
Yellow Hornet Hymenoptera Venom Multidose
Non-Proprietary Name: [1]
Yellow Hornet Hymenoptera Venom Multidose
Substance Name: [2]
Dolichovespula Arenaria Venom Protein
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Jubilant Hollisterstier Llc
    Labeler Code:
    65044
    FDA Application Number: [6]
    BLA103886
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-16-1979
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 65044-9942-5

    Package Description: 5.5 mL in 1 VIAL

    Product Details

    What is NDC 65044-9942?

    The NDC code 65044-9942 is assigned by the FDA to the product Yellow Hornet Hymenoptera Venom Multidose which is a standardized allergenic label product labeled by Jubilant Hollisterstier Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via percutaneous; subcutaneous form. The product is distributed in a single package with assigned NDC code 65044-9942-5 5.5 ml in 1 vial . 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 Yellow Hornet Hymenoptera Venom Multidose?

    Insect stings may induce a wide range of allergic symptoms in sensitive patients. A normal sting response is initial burning or stinging pain that may be intense and last several minutes to an hour or more. There is usually some local swelling coming on immediately and persisting for several days. The location of the sting has considerable influence on the intensity of the pain and extent of swelling. Stings on the fingers or feet produce much pain, but less swelling; whereas a sting on the head or face produces extensive swelling with variable pain. Local reactions coming on rapidly and larger than the usual local reaction, particularly if the swelling spans both adjacent joints on the extremities, can indicate hypersensitivity. Systemic symptoms come on shortly after the sting, often within seconds to minutes. Symptoms may range from generalized flushing, itching, redness, diffuse swelling of the skin or urticarial wheals, abdominal cramps, nausea, vomiting, or incontinence of urine or stool, to faintness, blurring or loss of vision, unconsciousness, seizures, respiratory or cardiac arrest, or death. Later reactions may consist of fever, achiness, malaise, joint swelling, urticaria or other signs of vascular damage typical of serum sickness, a Type III reaction. Typical delayed Type IV reactions may also occur.(6)Rarely, other types of severe reactions to insect stings have been reported.(6) These include serum sickness, hematologic abnormalities, and neurological disorders commencing some time after a sting, and not associated with anaphylactoid reactions. These patients are not candidates for immunotherapy using insect venoms. (1) DiagnosisSkin testing with insect venoms is useful to demonstrate the presence of IgE antibodies which account for the patient's symptoms.(3) Patients are seldom able to identify the insect which stung them, so skin testing is used to determine the insect culprit. Dilutions of these venom products will help judge the sensitivity of the patient and whether the patient should be treated.(7)It is not absolutely known what levels (micrograms) of venom, that elicit positive skin tests, are diagnostic of clinical sensitivity. However, patients with a history of reactions (any of three types: generalized urticaria or angioedema; respiratory difficulty due either to laryngeal edema or to bronchospasm; or vascular collapse, with or without loss of consciousness) to previous stings and a positive skin test to a venom intradermal injection of approximately 1 µg/mL had about a 60% chance of reacting again when stung by the same insect. These patients should receive venom immunotherapy.(3)Patients with a history of reaction (any of the three reaction types described above) to previous stings, but did not demonstrate a positive skin test reaction to venom, were considered in a previous study not to be clinically sensitive, and were not treated.(3) We cannot recommend treatment for such patients. Another study demonstrated false positive reactions when skin testing with venom concentrations of 10 µg/mL and 100 µg/mL was carried out.(8) Thus there can be a nonspecific skin test reaction potentially due to the pharmacological action of the venom at higher concentrations. The best statement that can be made, at present, is that patients with significant positive history (reactions of the three types described above) following an insect sting, and who do react with a positive skin test to a venom concentration of 1 µg/mL or less, are recommended for treatment. Patients who have the history described above, but do not react to a 1 µg/mL intradermal venom skin test, cannot be recommended for treatment. At present, the data does not exist to determine whether a patient who might react to a higher concentration, e.g., 2-10 µg/mL, is at risk from a subsequent sting or not. Since it is not known if sting-sensitive patients who subsequently lose their IgE anti-venom antibody can be re-sensitized by further stings, it is advisable to retest these patients after any subsequent stings.(3)However, since the level of venom-specific IgE may fall to low levels briefly after a sting, patients should not be re-tested until 2 to 4 weeks after any sting. (2) TreatmentImmunotherapy is indicated for those patients diagnosed as sensitive (see Diagnosis above) and is accomplished by using graduated dilutions of the appropriate insect venom or venoms to control the severity of the patient's symptoms from subsequent stings. Increasing doses of venom are given at intervals, dependent on the patient's ability to tolerate the venom, until a maintenance dosage (100 µg venom is recommended or 300 µg in the case of Mixed Vespid venom protein) is reached and maintained. Venom sensitivity differs for individual patients, thus it is not possible to provide a dosage schedule that is universally suited to all patients. The dosage schedule shown under DOSAGE AND ADMINISTRATION is a summary of the schedule used in clinical trials of our product and found suitable for the majority of patients. In highly sensitive patients, the physician may be required to use a modified dose schedule, based on the patient's sensitivity to and tolerance of the injections. Lower initial doses and smaller dosage increments than shown under DOSAGE AND ADMINISTRATION may be necessary.

    What are Yellow Hornet Hymenoptera Venom Multidose 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 Yellow Hornet Hymenoptera Venom Multidose UNII Codes?

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

    • APIS MELLIFERA VENOM (UNII: 76013O881M)
    • APIS MELLIFERA VENOM (UNII: 76013O881M) (Active Moiety)
    • DOLICHOVESPULA MACULATA VENOM PROTEIN (UNII: J8DAZ3T66L)
    • DOLICHOVESPULA MACULATA VENOM PROTEIN (UNII: J8DAZ3T66L) (Active Moiety)
    • DOLICHOVESPULA ARENARIA VENOM PROTEIN (UNII: 7PI26E943G)
    • DOLICHOVESPULA ARENARIA VENOM PROTEIN (UNII: 7PI26E943G) (Active Moiety)

    Which are Yellow Hornet Hymenoptera Venom Multidose 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 Yellow Hornet Hymenoptera Venom Multidose?

    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: 1294639 - common paper wasp venom protein 0.025 MG/mL / metricus paper wasp venom protein 0.025 MG/mL / northern paper wasp venom protein 0.025 MG/mL / red paper wasp venom protein 0.025 MG/mL Injectable Solution
    • RxCUI: 1294639 - common paper wasp venom protein 0.025 MG/ML / metricus paper wasp venom protein 0.025 MG/ML / northern paper wasp venom protein 0.025 MG/ML / red paper wasp venom protein 0.025 MG/ML Injectable Solution
    • RxCUI: 1294639 - Polistes exclamans venom protein 0.025 MG/ML / Polistes metricus venom protein 0.025 MG/ML / Polistes fuscatus venom protein 25 MCG / Polistes annularis venom protein 0.025 MG/ML Powder for Injectable Solution
    • RxCUI: 1294639 - Polistes exclamans venom protein 25 MCG / Polistes metricus venom protein 25 MCG / Polistes fuscatus venom protein 25 MCG / Polistes annularis venom protein 25 MCG per 1 ML Powder for Injectable Solution
    • RxCUI: 1297542 - bald-faced hornet venom protein 0.1 MG/mL / common wasp venom protein 0.02 MG/mL / eastern yellow jacket venom protein 0.02 MG/mL / German wasp venom protein 0.02 MG/mL / southern yellow jacket venom protein 0.02 MG/mL / western yellow jacket venom protein 0.02 MG/mL / yellow hornet venom protein 0.1 MG/mL Injectable Solution

    Which are the Pharmacologic Classes for Yellow Hornet Hymenoptera Venom Multidose?

    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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    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".