NDC 0268-1302 Sorrel/dock Mix

Rumex Acetosella Pollen And Rumex Crispus Pollen Injection, Solution Percutaneous; - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0268-1302
Proprietary Name:
Sorrel/dock Mix
Non-Proprietary Name: [1]
Rumex Acetosella Pollen And Rumex Crispus Pollen
Substance Name: [2]
Rumex Acetosella Pollen; Rumex Crispus Pollen
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.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Alk-abello, Inc.
    Labeler Code:
    0268
    FDA Application Number: [6]
    BLA103753
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-01-1965
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0268-1302-06

    Package Description: 5.5 mL in 1 VIAL

    NDC Code 0268-1302-10

    Package Description: 10 mL in 1 VIAL

    NDC Code 0268-1302-50

    Package Description: 53 mL in 1 VIAL

    Product Details

    What is NDC 0268-1302?

    The NDC code 0268-1302 is assigned by the FDA to the product Sorrel/dock Mix which is a non-standardized allergenic label product labeled by Alk-abello, Inc.. The generic name of Sorrel/dock Mix is rumex acetosella pollen and rumex crispus pollen. The product's dosage form is injection, solution and is administered via percutaneous; subcutaneous form. The product is distributed in 3 packages with assigned NDC codes 0268-1302-06 5.5 ml in 1 vial , 0268-1302-10 10 ml in 1 vial , 0268-1302-50 53 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 Sorrel/dock Mix?

    Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.

    What are Sorrel/dock 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 Sorrel/dock Mix UNII Codes?

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

    • CRAB LEG, UNSPECIFIED (UNII: S1VF61QLO9)
    • CRAB LEG, UNSPECIFIED (UNII: S1VF61QLO9) (Active Moiety)
    • SHRIMP, UNSPECIFIED (UNII: 1891LE191T)
    • SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (Active Moiety)
    • LOBSTER, UNSPECIFIED (UNII: ZQ6LG2C39M)
    • LOBSTER, UNSPECIFIED (UNII: ZQ6LG2C39M) (Active Moiety)
    • OYSTER, UNSPECIFIED (UNII: S614XWR17V)
    • OYSTER, UNSPECIFIED (UNII: S614XWR17V) (Active Moiety)
    • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C)
    • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (Active Moiety)
    • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK)
    • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (Active Moiety)
    • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO)
    • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (Active Moiety)
    • ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM)
    • ALNUS RHOMBIFOLIA POLLEN (UNII: 7X8HL8GRTM) (Active Moiety)
    • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
    • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
    • ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I)
    • ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (Active Moiety)
    • BETULA LENTA POLLEN (UNII: JQ5HI5004M)
    • BETULA LENTA POLLEN (UNII: JQ5HI5004M) (Active Moiety)
    • ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
    • ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
    • CARYA OVATA POLLEN (UNII: 54UN9R2798)
    • CARYA OVATA POLLEN (UNII: 54UN9R2798) (Active Moiety)
    • POPULUS ALBA POLLEN (UNII: VU8C8SB23P)
    • POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (Active Moiety)
    • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
    • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
    • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y)
    • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (Active Moiety)
    • ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
    • ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
    • ACER RUBRUM POLLEN (UNII: 700NK45C76)
    • ACER RUBRUM POLLEN (UNII: 700NK45C76) (Active Moiety)
    • PERIPLANETA AMERICANA (UNII: 2RQ1L9N089)
    • PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (Active Moiety)
    • BLATTELLA GERMANICA (UNII: G9O67I0A8Q)
    • BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (Active Moiety)
    • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M)
    • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (Active Moiety)
    • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI)
    • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (Active Moiety)
    • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
    • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
    • IVA ANNUA POLLEN (UNII: Y2U5S5PF22)
    • IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (Active Moiety)
    • PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG)
    • PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (Active Moiety)
    • COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W)
    • COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (Active Moiety)
    • ALTERNARIA ALTERNATA (UNII: 52B29REC7H)
    • ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (Active Moiety)
    • ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6)
    • ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (Active Moiety)
    • CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R)
    • CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (Active Moiety)
    • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
    • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (Active Moiety)
    • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW)
    • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (Active Moiety)
    • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
    • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
    • RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
    • RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)

    Which are Sorrel/dock 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 Sorrel/dock 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: 1735534 - American cockroach allergenic extract 50 MG/mL / German cockroach allergenic extract 50 MG/mL Injectable Solution
    • RxCUI: 1735534 - American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable Solution
    • RxCUI: 1735534 - Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable Solution
    • RxCUI: 1927623 - box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution
    • RxCUI: 1927623 - Acer negundo pollen extract 0.05 GM/ML / Acer rubrum pollen extract 0.05 GM/ML Injectable Solution

    Which are the Pharmacologic Classes for Sorrel/dock Mix?

    * 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".