Grastek Tablet
NDC Package 52709-1501-5

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

Grastek (timothy grass pollen allergen extract) tablets is a medication used to treat certain allergies that may occur seasonally or year round. This formulation utilizes a tablet delivery system. Marketed by Alk-abello A S, this product is identified by NDC 52709-1501 and is authorized under FDA application BLA125473.

Identification & Billing

NDC Package Code
52709-1501-5
Package Description
1 BLISTER PACK in 1 CARTON / 5 TABLET in 1 BLISTER PACK
Product Code
52709-1501
11-Digit Billing Format
52709150105
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Grastek
Non-Proprietary Name
Timothy Grass Pollen Allergen Extract
Substance Name
Phleum Pratense Pollen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
PHLEUM PRATENSE POLLEN 2800 [BAU]/1
Pharmacologic Class
Usage Information
This medication is used to treat certain allergies that may occur seasonally or year round. It is an extract of certain plant pollens that can cause allergies. Before prescribing this medication, your doctor must do laboratory/medical tests (such as skin or IgE tests) to learn what you are allergic to. This pollen allergen extract works by making your body less sensitive to the pollens (such as ragweed, grasses) that cause your allergies. This medication will not work right away to relieve allergy symptoms. When taken as directed, it may help relieve symptoms such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes that are caused by allergies.

Regulatory & Marketing

Labeler Name
Alk-abello A S
Product Type
Standardized Allergenic
FDA Application #
BLA125473
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-11-2014
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 (52709-1501). Click a package code to view its specific billing and regulatory data.

52709-1501-3
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (52709-1501-1)

* 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 52709-1501-5 identifies a specific commercial package of 1 blister pack in 1 carton / 5 tablet in 1 blister pack of Grastek, a standardized allergenic label labeled by Alk-abello A S. This tablet is formulated for sublingual use and contains phleum pratense 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 Alk-abello A S on April 11, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain allergies that may occur seasonally or year round. It is an extract of certain plant pollens that can cause allergies. Before prescribing this medication, your doctor must do laboratory/medical tests (such as skin or IgE tests) to learn what you are allergic to. This pollen allergen extract works by making your body less sensitive to the pollens (such as ragweed, grasses) that cause your allergies. This medication will not work right away to relieve allergy symptoms. When taken as directed, it may help relieve symptoms such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes that are caused by allergies.

How is this Alk-abello A S product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52709150105. 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)
52709-1501-5
11-Digit CMS (5-4-2)
52709-1501-05

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