NDC 22840-0038 Standardized Mite Dermatophagoides Farinae

Dermatophagoides Farinae Concentrate Intradermal; Percutaneous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
22840-0038
Proprietary Name:
Standardized Mite Dermatophagoides Farinae
Non-Proprietary Name: [1]
Dermatophagoides Farinae
Substance Name: [2]
Dermatophagoides Farinae
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route(s): [4]
  • Intradermal - Administration within the dermis.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Greer Laboratories, Inc.
    Labeler Code:
    22840
    FDA Application Number: [6]
    BLA101834
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    02-03-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 22840-0038-6

    Package Description: 10 mL in 1 VIAL, MULTI-DOSE

    NDC Code 22840-0038-8

    Package Description: 30 mL in 1 VIAL, MULTI-DOSE

    NDC Code 22840-0038-9

    Package Description: 50 mL in 1 VIAL, MULTI-DOSE

    Product Details

    What is NDC 22840-0038?

    The NDC code 22840-0038 is assigned by the FDA to the product Standardized Mite Dermatophagoides Farinae which is a human prescription drug product labeled by Greer Laboratories, Inc.. The generic name of Standardized Mite Dermatophagoides Farinae is dermatophagoides farinae. The product's dosage form is concentrate and is administered via intradermal; percutaneous; subcutaneous form. The product is distributed in 3 packages with assigned NDC codes 22840-0038-6 10 ml in 1 vial, multi-dose , 22840-0038-8 30 ml in 1 vial, multi-dose , 22840-0038-9 50 ml in 1 vial, multi-dose . 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 Standardized Mite Dermatophagoides Farinae?

    Greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated forskin test diagnosis of mite allergytreatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. farinae) or Dermatophagoides pteronyssinus (D. pteronyssinus) based on their clinical history, allergen exposure history, and skin test reactivity.

    What are Standardized Mite Dermatophagoides Farinae 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 Standardized Mite Dermatophagoides Farinae UNII Codes?

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

    • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q)
    • DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (Active Moiety)
    • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K)
    • DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Standardized Mite Dermatophagoides Farinae?

    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: 1014384 - European house dust mite extract 5000 AU/ML Injectable Solution
    • RxCUI: 1014384 - European house dust mite allergenic extract 5000 AU/ML Injectable Solution
    • RxCUI: 1014384 - Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable Solution
    • RxCUI: 1192764 - American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable Solution
    • RxCUI: 1192764 - American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable Solution

    Which are the Pharmacologic Classes for Standardized Mite Dermatophagoides Farinae?

    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.

    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".