Pollens - Trees, Oak, Red Quercus Rubra
NDC Package 65044-2016-5

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 inactivated by the FDA.

Pollens - Trees, Oak, Red Quercus Rubra is certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-2016 and is authorized under FDA application BLA103888.

Identification & Billing

NDC Package Code
65044-2016-5
Package Description
5 mL in 1 VIAL
Product Code
65044-2016
11-Digit Billing Format
65044201605
RxNorm Crosswalk
  • RxCUI: 1006369 - Canada goldenrod pollen extract 500 UNT/ML Injectable Solution
  • RxCUI: 1006369 - Solidago canadensis pollen extract 500 UNT/ML Injectable Solution
  • RxCUI: 1087970 - Mucor racemosus allergenic extract 1000 UNT/mL Injectable Solution
  • RxCUI: 1087970 - Mucor racemosus allergenic extract 1000 UNT/ML Injectable Solution
  • RxCUI: 1087970 - Mucor racemosus extract 1000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Pollens - Trees, Oak, Red Quercus Rubra
Dosage Form
-
Usage Information
Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
FDA Application #
BLA103888
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-19-1941
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65044-2016-5 identifies a specific commercial package of 5 ml in 1 vial of Pollens - Trees, Oak, Red Quercus Rubra, 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 April 19, 1941. The current certification is valid through December 31, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044201605. 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)
65044-2016-5
11-Digit CMS (5-4-2)
65044-2016-05

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