Standardized Bermuda Grass Pollen Solution
NDC 22840-0200

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 22840-0200?
  4. Standardized Bermuda Grass Pollen Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Standardized Bermuda Grass Pollen (cynodon dactylon) is a BLA-approved product labeled by Greer Laboratories, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a solution for intradermal; percutaneous; subcutaneous administration. This product entry covers the primary NDC 22840-0200 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
22840-0200
Proprietary Name:
Standardized Bermuda Grass Pollen
Non-Proprietary Name: [1]
Cynodon Dactylon
Substance Name: [2]
Cynodon Dactylon Pollen
NDC Directory Status:
Standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Greer Laboratories, Inc.
Labeler Code:
22840
Product Label ID:
60b8218f-84f0-1acc-e053-2991aa0a2795
FDA Application Number: [6]
BLA101836
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
09-15-1968
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 22840-0200?

The NDC code 22840-0200 is assigned by the FDA to the product Standardized Bermuda Grass Pollen. It is commonly known by its generic name, cynodon dactylon. This pharmaceutical product is labeled by Greer Laboratories, Inc. and is currently categorized as listed product. The medication is a solution administered via intradermal; percutaneous; subcutaneous route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 22840-0200-2, 22840-0200-4, 22840-0200-5. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated 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 the Inactive Ingredients associated 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 this product?

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 of this product?

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 & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".