Standardized Bermuda Grass Injection
NDC Package 49643-342-50

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 (cynodon dactylon) injection is standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. This formulation utilizes a injection delivery system. Marketed by Allermed Laboratories, Inc., this product is identified by NDC 49643-342 and is authorized under FDA application BLA102214.

Identification & Billing

NDC Package Code
49643-342-50
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
49643-342
11-Digit Billing Format
49643034250
RxNorm Crosswalk
  • RxCUI: 851873 - redtop grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 851873 - Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/mL Injectable Solution
  • RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/ML Injectable Solution
  • RxCUI: 852157 - Phleum pratense grass pollen extract 100,000 BAU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Bermuda Grass
Non-Proprietary Name
Cynodon Dactylon
Substance Name
Cynodon Dactylon Pollen
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Cutaneous - Administration to the skin.
  • Intradermal - Administration within the dermis.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
CYNODON DACTYLON POLLEN 10000 [BAU]/mL
Pharmacologic Class
Usage Information
Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook13. Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.

Regulatory & Marketing

Labeler Name
Allermed Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA102214
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-02-1996
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 (49643-342). Click a package code to view its specific billing and regulatory data.

49643-342-05
5 mL in 1 VIAL, MULTI-DOSE
49643-342-10
10 mL in 1 VIAL, MULTI-DOSE
49643-342-30
30 mL in 1 VIAL, MULTI-DOSE

* 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 49643-342-50 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Standardized Bermuda Grass, a human prescription drug labeled by Allermed Laboratories, Inc.. This injection is formulated for cutaneous; intradermal; 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 Allermed Laboratories, Inc. on December 02, 1996. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49643034250. 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 (5-3-2)
49643-342-50
11-Digit CMS (5-4-2)
49643-0342-50

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