NDC 65044-3381 Food - Dairy Products, Casein, Cow Milk

Casein,Cow Milk Injection, Solution Percutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
65044-3381
Proprietary Name:
Food - Dairy Products, Casein, Cow Milk
Non-Proprietary Name: [1]
Casein, Cow Milk
Substance Name: [2]
Casein
NDC Directory Status:
Non-standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Percutaneous - Administration through the skin.
  • Labeler Name: [5]
    Jubilant Hollisterstier Llc
    Labeler Code:
    65044
    FDA Application Number: [6]
    BLA103888
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-19-1941
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 65044-3381-1

    Package Description: 5 mL in 1 VIAL

    Product Details

    What is NDC 65044-3381?

    The NDC code 65044-3381 is assigned by the FDA to the product Food - Dairy Products, Casein, Cow Milk which is a non-standardized allergenic label product labeled by Jubilant Hollisterstier Llc. The generic name of Food - Dairy Products, Casein, Cow Milk is casein, cow milk. The product's dosage form is injection, solution and is administered via percutaneous form. The product is distributed in a single package with assigned NDC code 65044-3381-1 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 Food - Dairy Products, Casein, Cow Milk?

    Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied. Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

    What are Food - Dairy Products, Casein, Cow Milk 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.
    • CASEIN .1 g/mL - A mixture of related phosphoproteins occurring in milk and cheese. The group is characterized as one of the most nutritive milk proteins, containing all of the common amino acids and rich in the essential ones.

    Which are Food - Dairy Products, Casein, Cow Milk UNII Codes?

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

    Which are Food - Dairy Products, Casein, Cow Milk 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 Food - Dairy Products, Casein, Cow Milk?

    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: 1091110 - American cockroach allergenic extract 100 MG/ML / German cockroach allergenic extract 100 MG/ML Injectable Solution
    • RxCUI: 1091110 - Periplaneta americana allergenic extract 0.1 GM/ML / Blatella germanica allergenic extract 0.1 GM/ML Injectable Solution
    • RxCUI: 1091113 - black imported fire ant allergenic extract 100 MG/ML Injectable Solution
    • RxCUI: 1091113 - Solenopsis richteri extract 0.1 GM/ML Injectable Solution
    • RxCUI: 1091115 - black imported fire ant allergenic extract 100 MG/ML / red imported fire ant allergenic extract 100 MG/ML Injectable Solution

    Which are the Pharmacologic Classes for Food - Dairy Products, Casein, Cow Milk?

    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".