FDA.reportPublic FDA data

Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]

RxCUI
1666446
RxNorm name
Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]
Display name
Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]
Full name
Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:04

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125354SpherusolCoccidioides immitis Spherule-Derived Skin Test Antigen351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpherusolCOCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGENNielsen BioSciences, Inc.77108624-4771-4886-a3e2-b2625c444d1b2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1666446

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
77108624-4771-4886-a3e2-b2625c444d1bSpherusol 1.27 MCG in 0.1 ML Injectable Solution [PSN] · Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol] [SBD] · Spherusol 0.0127 MG/ML Injectable Solution [SY] · Spherusol 1.27 MCG per 0.1 ML Injectable Solution [SY]424These highlights do not include all the information needed to use Spherusol ® safely and effectively. See full prescribing information for Spherusol ® . Coccidioides immitis Spherule-Derived Skin Test Antigen- Spherusol ® Solution for Intradermal Injection Initial U.S. Approval: July 2011 Nielsen BioSciences, Inc. U.S. Lic. No. 1903 Mfd. by Allermed Laboratories, Inc. U.S. Lic. No. 046720250114