What is NDC 59584-140?

59584-140 is the product NDC for Spherusol, Coccidioides immitis spherule 12.7 ug/mL injection, solution, listed with the FDA by Nielsen BioSciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen).

Nielsen BioSciences, Inc., NDC labeler code 59584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Spherusol?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Spherusol NDC 59584-140 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59584-140Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59584-0140Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59584-140-01	59584014001	1 mL in 1 VIAL, MULTI-DOSE (59584-140-01)Marketed from Jun 1, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Spherusol
Generic name (nonproprietary): coccidioides immitis spherule-derived skin test antigen
Active ingredients: Coccidioides immitis spherule — 12.7 ug/mL
Dosage form: Injection, Solution
Route: Intradermal
Labeler: Nielsen BioSciences, Inc.NDC labeler code 59584
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125354
Marketing start: Jul 29, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Fungal (Chemical structure)Cell-mediated Immunity (Physiologic effect)
Identifiers: Product ID 59584-140_8de6697d-eeab-4f02-8edb-088960905daeSPL ID 8de6697d-eeab-4f02-8edb-088960905daeSPL set ID 77108624-4771-4886-a3e2-b2625c444d1bRxCUI 1666441, 1666446UNII ITY7G7Q744
Pharmacologic class: Skin Test Antigen

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N459584014001 followed by a unit qualifier and the quantity

Package 59584-0140-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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 ® . Spherusol ® is a skin tes…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59584-140

What is NDC 59584-140?: 59584-140 is the product NDC for Spherusol, Coccidioides immitis spherule 12.7 ug/mL injection, solution, listed with the FDA by Nielsen BioSciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen).
What is the active ingredient?: Coccidioides immitis spherule.
Who is the labeler?: Nielsen BioSciences, Inc., NDC labeler code 59584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Spherusol?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.