NDC 22840-0205 Standardized Orchard Grass Pollen

Dactylis Glomerata Solution Intradermal; Percutaneous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
22840-0205
Proprietary Name:
Standardized Orchard Grass Pollen
Non-Proprietary Name: [1]
Dactylis Glomerata
Substance Name: [2]
Dactylis Glomerata Pollen
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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]
    BLA101839
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    09-15-1968
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 22840-0205-2

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

    NDC Code 22840-0205-4

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

    NDC Code 22840-0205-5

    Package Description: 5 mL in 1 BOTTLE, DROPPER

    Product Details

    What is NDC 22840-0205?

    The NDC code 22840-0205 is assigned by the FDA to the product Standardized Orchard Grass Pollen which is a standardized allergenic label product labeled by Greer Laboratories, Inc.. The generic name of Standardized Orchard Grass Pollen is dactylis glomerata. The product's dosage form is solution and is administered via intradermal; percutaneous; subcutaneous form. The product is distributed in 3 packages with assigned NDC codes 22840-0205-2 10 ml in 1 vial, multi-dose , 22840-0205-4 50 ml in 1 vial, multi-dose , 22840-0205-5 5 ml in 1 bottle, dropper . 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 Orchard Grass Pollen?

    INDICATIONS AND USAGEStandardized Grass Pollen Extracts are indicated for the skin-test diagnosis of allergy and immunotherapy treatment of patients with a history of allergy to the respective pollen. The diagnosis of IgE-mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (8,11,15) Extracts at 10,000 BAU/mL are indicated for use in scratch, prick, or puncture skin test diagnosis. Extracts at 100,000 BAU/mL are indicated for use in scratch, prick, or puncture skin test diagnosis in less sensitive subjects, such as those negative or indeterminate upon scratch, prick, or puncture testing at 10,000 BAU/mL. Extracts at 10,000 BAU/mL or 100,000 BAU/mL are indicated for intradermal skin test diagnosis only when appropriately diluted. Immunotherapy with Standardized Grass Pollen Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (16-18) Extracts at 10,000 BAU/mL or 100,000 BAU/mL are indicated for immunotherapy only when appropriately diluted. 10,000 BAU/mL extracts are indicated for immunotherapy on previously untreated patients. 100,000 BAU/mL extracts are indicated if a higher dose is needed.(See DOSAGE AND ADMINISTRATION) STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/mL ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/mL OR WITH NONSTANDARDIZED GRASS POLLEN EXTRACTS. The use of Standardized Grass Pollen Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION)

    What are Standardized Orchard Grass Pollen 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 Orchard Grass Pollen UNII Codes?

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

    • FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1)
    • FESTUCA PRATENSIS POLLEN (UNII: A0WFQ8P6N1) (Active Moiety)
    • DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P)
    • DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (Active Moiety)
    • PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG)
    • PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (Active Moiety)
    • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T)
    • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (Active Moiety)
    • AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA)
    • AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (Active Moiety)
    • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0)
    • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (Active Moiety)
    • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y)
    • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (Active Moiety)
    • CYNODON DACTYLON POLLEN (UNII: 175F461W10)
    • CYNODON DACTYLON POLLEN (UNII: 175F461W10) (Active Moiety)

    Which are Standardized Orchard Grass Pollen 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 Standardized Orchard Grass Pollen?

    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: 1996815 - orchard grass pollen extract 5000 BAU/mL / Timothy grass pollen extract 5000 BAU/mL Injectable Solution
    • RxCUI: 1996815 - orchard grass pollen extract 5000 BAU/ML / Timothy grass pollen extract 5000 BAU/ML Injectable Solution
    • RxCUI: 1996815 - Dactylis glomerata pollen extract 5,000 BAU/ML / Phleum pratense grass pollen extract 5,000 BAU/ML Injectable Solution
    • RxCUI: 1996818 - orchard grass pollen extract 50,000 BAU/mL / Timothy grass pollen extract 50,000 BAU/mL Injectable Solution
    • RxCUI: 1996818 - orchard grass pollen extract 50000 BAU/ML / Timothy grass pollen extract 50000 BAU/ML Injectable Solution

    Which are the Pharmacologic Classes for Standardized Orchard Grass Pollen?

    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".