Standardized Mite Dermatophagoides Farinae
NDC Package 36987-1844-2

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 Mite Dermatophagoides Farinae is standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10). Marketed by Nelco Laboratories, Inc., this product is identified by NDC 36987-1844 and is authorized under FDA application BLA102193.

Identification & Billing

NDC Package Code
36987-1844-2
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
36987-1844
11-Digit Billing Format
36987184402
RxNorm Crosswalk
  • RxCUI: 852825 - American house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - American house dust mite allergenic extract 10000 AU/ML Injectable Solution
  • RxCUI: 852825 - Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite extract 10000 AU/ML Injectable Solution
  • RxCUI: 852829 - European house dust mite allergenic extract 10000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Mite Dermatophagoides Farinae
Dosage Form
-
Usage Information
Standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10). Standardized Mite extracts are not interchangeable with non standardized mite extracts. To select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13)Standardized mite extract containing equal parts of D.farinae and D.pteronyssinus is intended for therapy only. The use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. This treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests.

Regulatory & Marketing

Labeler Name
Nelco Laboratories, Inc.
FDA Application #
BLA102193
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-12-1987
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 (36987-1844). Click a package code to view its specific billing and regulatory data.

36987-1844-1
5 mL in 1 VIAL, MULTI-DOSE
36987-1844-3
30 mL in 1 VIAL, MULTI-DOSE
36987-1844-4
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 36987-1844-2 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Standardized Mite Dermatophagoides Farinae, 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 June 12, 1987. 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: 36987184402. 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)
36987-1844-2
11-Digit CMS (5-4-2)
36987-1844-02

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