Standardized Timothy Grass Pollen
NDC Package 36987-2402-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Standardized Timothy Grass Pollen is standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Marketed by Nelco Laboratories, Inc., this product is identified by NDC 36987-2402 and is authorized under FDA application BLA102202.

Identification & Billing

NDC Package Code
36987-2402-2
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
36987-2402
11-Digit Billing Format
36987240202
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 Timothy Grass Pollen
Dosage Form
-
Usage Information
Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration)The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.

Regulatory & Marketing

Labeler Name
Nelco Laboratories, Inc.
FDA Application #
BLA102202
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-10-1998
Listing Expiration
12-31-2017
Exclude Flag
I
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 (36987-2402). Click a package code to view its specific billing and regulatory data.

36987-2402-1
5 mL in 1 VIAL, MULTI-DOSE
36987-2402-3
30 mL in 1 VIAL, MULTI-DOSE
36987-2402-4
50 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 36987-2402-2 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Standardized Timothy Grass Pollen, labeled by Nelco Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nelco Laboratories, Inc. on February 10, 1998. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36987240202. 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)
36987-2402-2
11-Digit CMS (5-4-2)
36987-2402-02

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