House Dust Mite, Dermatophagoides Pteronyssinus Injection
NDC Package 49643-704-30

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

House Dust Mite, Dermatophagoides Pteronyssinus injection is standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing. This formulation utilizes a injection delivery system. Marketed by Allermed Laboratories, Inc., this product is identified by NDC 49643-704 and is authorized under FDA application BLA102213.

Identification & Billing

NDC Package Code
49643-704-30
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
49643-704
11-Digit Billing Format
49643070430
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
House Dust Mite, Dermatophagoides Pteronyssinus
Non-Proprietary Name
House Dust Mite, Dermatophagoides Pteronyssinus
Substance Name
Dermatophagoides Pteronyssinus
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Cutaneous - Administration to the skin.
  • Intradermal - Administration within the dermis.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL
Pharmacologic Class
Usage Information
Standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing. The use of mite extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook 10.

Regulatory & Marketing

Labeler Name
Allermed Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA102213
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-24-1986
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 (49643-704). Click a package code to view its specific billing and regulatory data.

49643-704-05
5 mL in 1 VIAL, MULTI-DOSE
49643-704-10
10 mL in 1 VIAL, MULTI-DOSE
49643-704-50
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 49643-704-30 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of House Dust Mite, Dermatophagoides Pteronyssinus, a human prescription drug labeled by Allermed Laboratories, Inc.. This injection is formulated for cutaneous; intradermal; subcutaneous use and contains dermatophagoides pteronyssinus 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 Allermed Laboratories, Inc. on December 24, 1986. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49643070430. 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 (5-3-2)
49643-704-30
11-Digit CMS (5-4-2)
49643-0704-30

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