Standardized Bermuda Grass Pollen Solution
NDC Package 22840-0200-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Standardized Bermuda Grass Pollen (cynodon dactylon) solution is 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. This formulation utilizes a solution delivery system. Marketed by Greer Laboratories, Inc., this product is identified by NDC 22840-0200 and is authorized under FDA application BLA101836.

Identification & Billing

NDC Package Code
22840-0200-2
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
22840-0200
11-Digit Billing Format
22840020002
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Standardized Bermuda Grass Pollen
Non-Proprietary Name
Cynodon Dactylon
Substance Name
Cynodon Dactylon Pollen
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
  • Intradermal - Administration within the dermis.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
CYNODON DACTYLON POLLEN 10000 [BAU]/mL
Pharmacologic Class
Usage Information
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)

Regulatory & Marketing

Labeler Name
Greer Laboratories, Inc.
Product Type
Standardized Allergenic
FDA Application #
BLA101836
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-15-1968
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (22840-0200). Click a package code to view its specific billing and regulatory data.

22840-0200-4
50 mL in 1 VIAL, MULTI-DOSE
22840-0200-5
5 mL in 1 BOTTLE, DROPPER

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 22840-0200-2 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Standardized Bermuda Grass Pollen, a standardized allergenic label labeled by Greer Laboratories, Inc.. This solution is formulated for intradermal; percutaneous; subcutaneous use and contains cynodon dactylon pollen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Greer Laboratories, Inc. on September 15, 1968. The current certification is valid through December 31, 2026.

How is this Greer Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 22840020002. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
22840-0200-2
11-Digit CMS (5-4-2)
22840-0200-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.