Positive Skin Test Control - Histamine Injection
NDC Package 65044-9998-1

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

Package Information

Positive Skin Test Control - Histamine (histamine) injection is positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts. This formulation utilizes a injection delivery system. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-9998 and is authorized under FDA application BLA103891.

Identification & Billing

NDC Package Code
65044-9998-1
Package Description
5 mL in 1 VIAL
Product Code
65044-9998
11-Digit Billing Format
65044999801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML

Clinical Specifications

Proprietary Name
Positive Skin Test Control - Histamine
Non-Proprietary Name
Histamine
Substance Name
Histamine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Percutaneous - Administration through the skin.
Active Ingredient(s)
HISTAMINE 6 mg/mL
Usage Information
Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
Product Type
Human Prescription Drug
FDA Application #
BLA103891
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-15-1995
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65044-9998-1 identifies a specific commercial package of 5 ml in 1 vial of Positive Skin Test Control - Histamine, a human prescription drug labeled by Jubilant Hollisterstier Llc. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This injection is formulated for percutaneous use and contains histamine 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 June 15, 1995. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044999801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 total billable units per package. 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)
65044-9998-1
11-Digit CMS (5-4-2)
65044-9998-01

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