Histamine Positive Injection, Solution
NDC Package 0268-0248-05

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

Package Information

Histamine Positive (histamine phosphate) injection is for use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing. This formulation utilizes a injection, solution delivery system. Marketed by Alk-abello, Inc., this product is identified by NDC 0268-0248 and is authorized under FDA application BLA103754.

Identification & Billing

NDC Package Code
0268-0248-05
Package Description
5 mL in 1 VIAL, MULTI-DOSE
Product Code
0268-0248
11-Digit Billing Format
00268024805
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
Histamine Positive Skin Test Control
Non-Proprietary Name
Histamine Phosphate
Substance Name
Histamine Phosphate
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
Intradermal - Administration within the dermis.
Active Ingredient(s)
HISTAMINE PHOSPHATE .275 mg/mL
Usage Information
For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA103754
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-23-1989
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0268-0248-05 identifies a specific commercial package of 5 ml in 1 vial, multi-dose of Histamine Positive Skin Test Control, a human prescription drug labeled by Alk-abello, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This injection, solution is formulated for intradermal use and contains histamine phosphate 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 Alk-abello, Inc. on October 23, 1989. The current certification is valid through December 31, 2026.

How is this Alk-abello, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00268024805. 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 (4-4-2)
0268-0248-05
11-Digit CMS (5-4-2)
00268-0248-05

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