Spherusol Injection, Solution
NDC Package 59584-140-01

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

Package Information

Spherusol (coccidioides immitis spherule-derived skin test antigen) injection is spherusol ® is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis. This formulation utilizes a injection, solution delivery system. Marketed by Nielsen Biosciences, Inc., this product is identified by NDC 59584-140 and is authorized under FDA application BLA125354.

Identification & Billing

NDC Package Code
59584-140-01
Package Description
1 mL in 1 VIAL, MULTI-DOSE
Product Code
59584-140
11-Digit Billing Format
59584014001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
RxNorm Crosswalk
  • RxCUI: 1666441 - Coccidioides immitis spherule 1.27 MCG in 0.1 ML Injectable Solution
  • RxCUI: 1666441 - Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution
  • RxCUI: 1666441 - Coccidioides immitis spherule 1.27 MCG per 0.1 ML Injectable Solution
  • RxCUI: 1666446 - Spherusol 1.27 MCG in 0.1 ML Injectable Solution
  • RxCUI: 1666446 - Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]

Clinical Specifications

Proprietary Name
Spherusol
Non-Proprietary Name
Coccidioides Immitis Spherule-derived Skin Test Antigen
Substance Name
Coccidioides Immitis Spherule
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)
COCCIDIOIDES IMMITIS SPHERULE 12.7 ug/mL
Pharmacologic Class
Usage Information
Spherusol ® is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis. Spherusol ® is approved for use in individuals 18-64 years of age. The use of Spherusol ® to detect delayed-type hypersensitivity responses in a general population with unknown exposure to C. immitis has not been evaluated. Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol ®. Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol ®.

Regulatory & Marketing

Labeler Name
Nielsen Biosciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125354
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-29-2011
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 59584-140-01 identifies a specific commercial package of 1 ml in 1 vial, multi-dose of Spherusol, a human prescription drug 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 coccidioides immitis spherule 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 July 29, 2011. 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: 59584014001. 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)
59584-140-01
11-Digit CMS (5-4-2)
59584-0140-01

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