Standardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml
NDC Package 65044-6721-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Standardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml is 16, 17, 18, 26 Standardized glycerinated allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-6721 and is authorized under FDA application BLA103870.

Identification & Billing

NDC Package Code
65044-6721-5
Package Description
5 mL in 1 VIAL
Product Code
65044-6721
11-Digit Billing Format
65044672105
RxNorm Crosswalk
  • RxCUI: 1192764 - American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable Solution
  • RxCUI: 1192764 - American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable Solution
  • RxCUI: 1192764 - American house dust mite extract 15,000 AU/ML / European house dust mite extract 15,000 AU/ML Injectable Solution
  • RxCUI: 1192764 - Dermatophagoides farinae extract 15,000 AU/ML / Dermatophagoides pteronyssinus extract 15,000 AU/ML Injectable Solution
  • RxCUI: 1192787 - Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution

Clinical Specifications

Proprietary Name
Standardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml
Dosage Form
-
Usage Information
16, 17, 18, 26 Standardized glycerinated allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.20, 21The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
FDA Application #
BLA103870
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-26-1988
End Marketing Date
12-15-2016
Listing Expiration
12-15-2016
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65044-6721-5 identifies a specific commercial package of 5 ml in 1 vial of Standardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml, labeled by Jubilant Hollisterstier Llc. 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 Jubilant Hollisterstier Llc on May 26, 1988. The current certification is valid through December 15, 2016.

How is this Jubilant Hollisterstier Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044672105. 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)
65044-6721-5
11-Digit CMS (5-4-2)
65044-6721-05

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