NDC 22840-9440 Pine Pollen Mix

Pinus Taeda,Pinus Strobus And Pinus Echinata Solution Intradermal; Percutaneous; - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
22840-9440
Proprietary Name:
Pine Pollen Mix
Non-Proprietary Name: [1]
Pinus Taeda, Pinus Strobus And Pinus Echinata
Substance Name: [2]
Pinus Echinata Pollen; Pinus Strobus Pollen; Pinus Taeda Pollen
NDC Directory Status:
Non-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]
    BLA101833
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    09-15-1981
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 22840-9440-2

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

    NDC Code 22840-9440-4

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

    NDC Code 22840-9440-5

    Package Description: 5 mL in 1 BOTTLE, DROPPER

    Product Details

    What is NDC 22840-9440?

    The NDC code 22840-9440 is assigned by the FDA to the product Pine Pollen Mix which is a non-standardized allergenic label product labeled by Greer Laboratories, Inc.. The generic name of Pine Pollen Mix is pinus taeda, pinus strobus and pinus echinata. 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 22840-9440-2 10 ml in 1 vial, multi-dose , 22840-9440-4 50 ml in 1 vial, multi-dose , 22840-9440-5 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 Pine Pollen Mix?

    Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic 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. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION)

    What are Pine Pollen Mix 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 Pine Pollen Mix UNII Codes?

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

    • FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX)
    • FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX) (Active Moiety)
    • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
    • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
    • BETULA LENTA POLLEN (UNII: JQ5HI5004M)
    • BETULA LENTA POLLEN (UNII: JQ5HI5004M) (Active Moiety)
    • BETULA NIGRA POLLEN (UNII: 93963RFO1P)
    • BETULA NIGRA POLLEN (UNII: 93963RFO1P) (Active Moiety)
    • BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U)
    • BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (Active Moiety)
    • PINUS ECHINATA POLLEN (UNII: 96LRW14765)
    • PINUS ECHINATA POLLEN (UNII: 96LRW14765) (Active Moiety)
    • PINUS TAEDA POLLEN (UNII: 4O1FFR8ARN)
    • PINUS TAEDA POLLEN (UNII: 4O1FFR8ARN) (Active Moiety)
    • PINUS STROBUS POLLEN (UNII: TX1ER5UV3T)
    • PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (Active Moiety)
    • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD)
    • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (Active Moiety)
    • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
    • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
    • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR)
    • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (Active Moiety)
    • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN)
    • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (Active Moiety)
    • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4)
    • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (Active Moiety)
    • ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
    • ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
    • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP)
    • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (Active Moiety)
    • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C)
    • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (Active Moiety)
    • CARYA OVATA POLLEN (UNII: 54UN9R2798)
    • CARYA OVATA POLLEN (UNII: 54UN9R2798) (Active Moiety)
    • JUGLANS CALIFORNICA POLLEN (UNII: 2147EPR64I)
    • JUGLANS CALIFORNICA POLLEN (UNII: 2147EPR64I) (Active Moiety)
    • JUGLANS REGIA POLLEN (UNII: ARW43087I1)
    • JUGLANS REGIA POLLEN (UNII: ARW43087I1) (Active Moiety)
    • JUNIPERUS SCOPULORUM POLLEN (UNII: 0G82TT8ZFY)
    • JUNIPERUS SCOPULORUM POLLEN (UNII: 0G82TT8ZFY) (Active Moiety)
    • JUNIPERUS MONOSPERMA POLLEN (UNII: PM6E3FG1QK)
    • JUNIPERUS MONOSPERMA POLLEN (UNII: PM6E3FG1QK) (Active Moiety)
    • ACACIA DEALBATA POLLEN (UNII: L16Z5HLP8V)
    • ACACIA DEALBATA POLLEN (UNII: L16Z5HLP8V) (Active Moiety)
    • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627)
    • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (Active Moiety)
    • ULMUS PUMILA POLLEN (UNII: 030R993R8E)
    • ULMUS PUMILA POLLEN (UNII: 030R993R8E) (Active Moiety)
    • ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
    • ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
    • POPULUS FREMONTII POLLEN (UNII: 426RHB4302)
    • POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (Active Moiety)
    • BETULA OCCIDENTALIS POLLEN (UNII: R889N2L976)
    • BETULA OCCIDENTALIS POLLEN (UNII: R889N2L976) (Active Moiety)
    • JUNIPERUS OCCIDENTALIS POLLEN (UNII: 7JWJ3HXZ9U)
    • JUNIPERUS OCCIDENTALIS POLLEN (UNII: 7JWJ3HXZ9U) (Active Moiety)
    • PLATANUS RACEMOSA POLLEN (UNII: BWC8DYU8OS)
    • PLATANUS RACEMOSA POLLEN (UNII: BWC8DYU8OS) (Active Moiety)
    • QUERCUS GARRYANA POLLEN (UNII: QQ00BED0DV)
    • QUERCUS GARRYANA POLLEN (UNII: QQ00BED0DV) (Active Moiety)
    • MORUS ALBA POLLEN (UNII: 3I9T68187H)
    • MORUS ALBA POLLEN (UNII: 3I9T68187H) (Active Moiety)
    • ACER RUBRUM POLLEN (UNII: 700NK45C76)
    • ACER RUBRUM POLLEN (UNII: 700NK45C76) (Active Moiety)
    • ACER SACCHARINUM POLLEN (UNII: 95447163DG)
    • ACER SACCHARINUM POLLEN (UNII: 95447163DG) (Active Moiety)
    • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y)
    • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (Active Moiety)
    • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO)
    • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (Active Moiety)
    • QUERCUS VELUTINA POLLEN (UNII: 294L626TT0)
    • QUERCUS VELUTINA POLLEN (UNII: 294L626TT0) (Active Moiety)
    • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK)
    • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (Active Moiety)
    • CARYA GLABRA POLLEN (UNII: KPO1Z9N98A)
    • CARYA GLABRA POLLEN (UNII: KPO1Z9N98A) (Active Moiety)
    • CARYA ALBA POLLEN (UNII: G2A764T54B)
    • CARYA ALBA POLLEN (UNII: G2A764T54B) (Active Moiety)
    • CARYA LACINIOSA POLLEN (UNII: 5BGG872373)
    • CARYA LACINIOSA POLLEN (UNII: 5BGG872373) (Active Moiety)

    Which are Pine Pollen Mix 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 Pine Pollen Mix?

    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: 1299992 - American elm pollen extract 25 MG/mL / Siberian elm pollen extract 25 MG/mL Injectable Solution
    • RxCUI: 1299992 - American elm pollen extract 25 MG/ML / Siberian elm pollen extract 25 MG/ML Injectable Solution
    • RxCUI: 1299992 - Ulmus americana pollen extract 0.025 GM/ML / Ulmus pumila pollen extract 0.025 GM/ML Injectable Solution
    • RxCUI: 1927683 - pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution
    • RxCUI: 1927683 - Carya illinoinensis pollen 0.05 GM/ML / Carya ovata pollen extract 0.05 GM/ML Injectable Solution

    Which are the Pharmacologic Classes for Pine Pollen Mix?

    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".