Candin Injection, Solution
NDC Package 59584-138-01

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

Package Information

Candin (candida albicans skin test antigen) injection is cANDIN is indicated for use as a recall antigen for detecting cell-mediated hypersensitivity by intracutaneous (intradermal) testing. This formulation utilizes a injection, solution delivery system. Marketed by Nielsen Biosciences, Inc., this product is identified by NDC 59584-138 and is authorized under FDA application BLA103257.

Identification & Billing

NDC Package Code
59584-138-01
Package Description
1 mL in 1 VIAL, MULTI-DOSE
Product Code
59584-138
11-Digit Billing Format
59584013801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML

Clinical Specifications

Proprietary Name
Candin
Non-Proprietary Name
Candida Albicans Skin Test Antigen
Substance Name
Candida Albicans
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)
CANDIDA ALBICANS 1 U/.1mL
Pharmacologic Class
Usage Information
CANDIN is indicated for use as a recall antigen for detecting cell-mediated hypersensitivity by intracutaneous (intradermal) testing. The product may be useful in evaluating the cellular immune response in patients suspected of having reduced cellular hypersensitivity. Because some persons with normal cellular immunity are not hypersensitive to Candida, a response rate less than 100% to the antigen is to be expected in normal individuals. Therefore, the concurrent use of other licensed cell-mediated hypersensitivity skin test antigens is recommended. The product should not be used to diagnose or treat Type 1 allergy to Candida albicans. The potency of CANDIN is measured by DTH skin tests in humans. The procedure involves concurrent (side-by-side) testing of production lots with an Internal Reference (IR), using sensitive adults who have been previously screened and qualified to serve as test subjects. The induration response at 48 hours elicited by 0.1 mL of a production lot is measured and compared to the response elicited by 0.1 mL of the IR. The test is satisfactory if the potency of the production lot does not differ more than ± 20% from the potency of the IR, when analyzed by the paired t-test (two-tailed) at a p value of 0.05.The potency of the IR is monitored by DTH skin testing. Persons included in the potency assay are qualified as test subjects by receiving four skin tests with the IR from which a mean induration response (mm) is calculated. Current skin tests with the IR must show that the potency of the IR has not changed more than ± 20% from the mean qualifying response in the same test subjects, when analyzed by the paired t-test (two-tailed) at a p value of 0.05. The required induration response at 48 hours to the IR is 15 mm ± 20%.

Regulatory & Marketing

Labeler Name
Nielsen Biosciences, Inc.
Product Type
Standardized Allergenic
FDA Application #
BLA103257
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-01-1995
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 59584-138-01 identifies a specific commercial package of 1 ml in 1 vial, multi-dose of Candin, a standardized allergenic label labeled by Nielsen Biosciences, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intradermal use and contains candida albicans 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 Nielsen Biosciences, Inc. on December 01, 1995. The current certification is valid through December 31, 2026.

How is this Nielsen Biosciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59584013801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 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 (5-3-2)
59584-138-01
11-Digit CMS (5-4-2)
59584-0138-01

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