Standardized Grass Pollen, Redtop Injection, Solution
NDC Package 65044-0778-1

11-digit billing NDC: 65044077801
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Standardized Grass Pollen, Redtop injection is standardized Grass Pollen Extracts [see Description (11)] are indicated for:Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. This formulation utilizes a injection, solution delivery system. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-0778 and is authorized under FDA application BLA103876.

Identification & Billing

NDC Package Code
65044-0778-1
Package Description
5 mL in 1 VIAL
Product Code
65044-0778
11-Digit Billing Format
65044077801
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 100000 [BAU]/mL
Pharmacologic Class
Usage Information
Standardized Grass Pollen Extracts [see Description (11)] are indicated for:Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.

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 (65044-0778). Click a package code to view its specific billing and regulatory data.

65044-0778-2
10 mL in 1 VIAL
65044-0778-2
10 mL in 1 VIAL
65044-0778-3
30 mL in 1 VIAL
65044-0778-3
30 mL in 1 VIAL
65044-0778-4
50 mL in 1 VIAL
65044-0778-4
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 65044-0778-1 identifies a specific commercial package of 5 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: 65044077801. 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)
65044-0778-1
11-Digit CMS (5-4-2)
65044-0778-01

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