Standardized Mite Dermatophagoides Pteronyssinus Concentrate
NDC Package 22840-0039-9

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

Standardized Mite Dermatophagoides Pteronyssinus (dermatophagoides pteronyssinus) concentrates is greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated forskin test diagnosis of mite allergytreatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. This formulation utilizes a concentrate delivery system. Marketed by Greer Laboratories, Inc., this product is identified by NDC 22840-0039 and is authorized under FDA application BLA101835.

Identification & Billing

NDC Package Code
22840-0039-9
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
22840-0039
11-Digit Billing Format
22840003909
RxNorm Crosswalk
  • RxCUI: 1014384 - European house dust mite extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - European house dust mite allergenic extract 5000 AU/ML Injectable Solution
  • RxCUI: 1014384 - Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable Solution
  • RxCUI: 1192787 - Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution
  • RxCUI: 1192787 - American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Mite Dermatophagoides Pteronyssinus
Non-Proprietary Name
Dermatophagoides Pteronyssinus
Substance Name
Dermatophagoides Pteronyssinus
Dosage Form
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route
  • Intradermal - Administration within the dermis.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DERMATOPHAGOIDES PTERONYSSINUS 30000 [AU]/mL
Pharmacologic Class
Usage Information
Greer Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated forskin test diagnosis of mite allergytreatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. farinae) or Dermatophagoides pteronyssinus (D. pteronyssinus) based on their clinical history, allergen exposure history, and skin test reactivity.

Regulatory & Marketing

Labeler Name
Greer Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA101835
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-03-2010
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 (22840-0039). Click a package code to view its specific billing and regulatory data.

22840-0039-6
10 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 22840-0039-9 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Standardized Mite Dermatophagoides Pteronyssinus, a human prescription drug labeled by Greer Laboratories, Inc.. This concentrate is formulated for intradermal; percutaneous; 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 Greer Laboratories, Inc. on February 03, 2010. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 22840003909. 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)
22840-0039-9
11-Digit CMS (5-4-2)
22840-0039-09

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