Standardized Grass Pollen, Redtop Injection, Solution
NDC Package 65044-0777-2

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 Grass Pollen, Redtop injection is 16, 17, 18, 20 Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. This formulation utilizes a injection, solution delivery system. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-0777 and is authorized under FDA application BLA103876.

Identification & Billing

NDC Package Code
65044-0777-2
Package Description
10 mL in 1 VIAL
Product Code
65044-0777
11-Digit Billing Format
65044077702
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: 851881 - orchard grass pollen extract 10000 BAU/ML Injectable Solution
  • RxCUI: 851881 - Dactylis glomerata pollen extract 10,000 BAU/ML Injectable Solution
  • RxCUI: 851901 - sweet vernal grass pollen extract 10000 BAU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Grass Pollen, Redtop
Non-Proprietary Name
Standardized Grass Pollen, Redtop
Substance Name
Agrostis Gigantea Pollen
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
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL
Pharmacologic Class
Usage Information
16, 17, 18, 20 Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used.The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
Product Type
Standardized Allergenic
FDA Application #
BLA103876
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-15-1998
Listing Expiration
12-31-2027
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 (65044-0777). Click a package code to view its specific billing and regulatory data.

65044-0777-1
5 mL in 1 VIAL
65044-0777-1
5 mL in 1 VIAL
65044-0777-3
30 mL in 1 VIAL
65044-0777-3
30 mL in 1 VIAL
65044-0777-4
50 mL in 1 VIAL
65044-0777-4
50 mL in 1 VIAL

* 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 65044-0777-2 identifies a specific commercial package of 10 ml in 1 vial of Standardized Grass Pollen, Redtop, a standardized allergenic label labeled by Jubilant Hollisterstier Llc. This injection, solution is formulated for percutaneous; subcutaneous use and contains agrostis gigantea 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 Jubilant Hollisterstier Llc on January 15, 1998. The current certification is valid through December 31, 2027.

How is this Jubilant Hollisterstier Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044077702. 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)
65044-0777-2
11-Digit CMS (5-4-2)
65044-0777-02

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