Food - Fish And Shellfish, Clam
NDC Package 65044-3192-1

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.

Food - Fish And Shellfish, Clam is certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-3192 and is authorized under FDA application BLA103888.

Identification & Billing

NDC Package Code
65044-3192-1
Package Description
5 mL in 1 VIAL
Product Code
65044-3192
11-Digit Billing Format
65044319201

Clinical Specifications

Proprietary Name
Food - Fish And Shellfish, Clam
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. 14In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied. Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

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
End Marketing Date
01-25-2017
Listing Expiration
01-25-2017
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 65044-3192-1 identifies a specific commercial package of 5 ml in 1 vial of Food - Fish And Shellfish, Clam, 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 January 25, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044319201. 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)
65044-3192-1
11-Digit CMS (5-4-2)
65044-3192-01

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