Insects Whole Body, Ant, Fire Solenopsis Invicta Injection, Solution
NDC Package 65044-6513-2

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

Insects Whole Body, Ant, Fire Solenopsis Invicta (ant, fire solenopsis invicta) injection is certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. This formulation utilizes a injection, solution delivery system. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-6513 and is authorized under FDA application BLA103888.

Identification & Billing

NDC Package Code
65044-6513-2
Package Description
10 mL in 1 VIAL
Product Code
65044-6513
11-Digit Billing Format
65044651302
RxNorm Crosswalk
  • RxCUI: 1091110 - American cockroach allergenic extract 100 MG/ML / German cockroach allergenic extract 100 MG/ML Injectable Solution
  • RxCUI: 1091110 - Periplaneta americana allergenic extract 0.1 GM/ML / Blatella germanica allergenic extract 0.1 GM/ML Injectable Solution
  • RxCUI: 1091113 - black imported fire ant allergenic extract 100 MG/ML Injectable Solution
  • RxCUI: 1091113 - Solenopsis richteri extract 0.1 GM/ML Injectable Solution
  • RxCUI: 1091115 - black imported fire ant allergenic extract 100 MG/ML / red imported fire ant allergenic extract 100 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Insects Whole Body, Ant, Fire Solenopsis Invicta
Non-Proprietary Name
Ant, Fire Solenopsis Invicta
Substance Name
Solenopsis Invicta
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Percutaneous - Administration through the skin.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
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
Product Type
Non-standardized Allergenic
FDA Application #
BLA103888
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-19-1941
Listing Expiration
12-31-2026
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 (65044-6513). Click a package code to view its specific billing and regulatory data.

65044-6513-1
5 mL in 1 VIAL

* 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 65044-6513-2 identifies a specific commercial package of 10 ml in 1 vial of Insects Whole Body, Ant, Fire Solenopsis Invicta, a non-standardized allergenic label labeled by Jubilant Hollisterstier Llc. This injection, solution is formulated for percutaneous; subcutaneous use and contains solenopsis invicta 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 Jubilant Hollisterstier Llc on April 19, 1941. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044651302. 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)
65044-6513-2
11-Digit CMS (5-4-2)
65044-6513-02

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