FDA.reportPublic FDA data

Spherusol

Product NDC
59584-140
Requested package NDC
59584-140-01
11-digit product format
595840140
Labeler code
59584
Product ID
59584-140_bf50b2c3-232b-4d0e-830e-5e9fe424b5b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Coccidioides immitis Spherule-Derived Skin Test Antigen
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL
Labeler
Nielsen BioSciences, Inc.
Application
BLA125354
Marketing category
BLA
Marketing start
2011-07-29
Substance
COCCIDIOIDES IMMITIS SPHERULE
Active strength
12.7 ug/mL
Pharmacologic classes
Antigens, Fungal [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59584-14059584-140-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59584-14059584-140-01IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59584-14059584-140-01IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Spherusol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCCIDIOIDES IMMITIS SPHERULE12.7 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ITY7G7Q744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1666441Internal RxNorm lookup
1666446Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77108624-4771-4886-a3e2-b2625c444d1bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-06-14These 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. 0467
2022-06-14These 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. 0467
2022-01-28These 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. 0467
2022-01-28These 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. 0467

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59584-140-01Spherusol1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59584-140-01ML - Milliliter59584-140ad2d0671-587e-4c9a-a38c-45d4e8398df412014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCCIDIOIDES IMMITIS SPHERULEACTIVE INGREDIENTITY7G7Q744SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5
COCCIDIOIDES IMMITIS SPHERULEACTIVE MOIETYITY7G7Q744SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5
PHENOLINACTIVE INGREDIENT339NCG44TVSPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOSPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RSPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59584-140SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.]24Current NDC, Legacy NDC, 1 package rows20250116_77108624-4771-4886-a3e2-b2625c444d1b.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125354SpherusolCoccidioides immitis Spherule-Derived Skin Test Antigen351(a)Rx2026-10-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666441Coccidioides immitis spherule 1.27 MCG in 0.1 ML Injectable SolutionPSN77108624-4771-4886-a3e2-b2625c444d1b24
1666446Spherusol 1.27 MCG in 0.1 ML Injectable SolutionPSN77108624-4771-4886-a3e2-b2625c444d1b24
1666446Coccidioides immitis spherule 0.0127 MG/ML Injectable Solution [Spherusol]SBD77108624-4771-4886-a3e2-b2625c444d1b24
1666441Coccidioides immitis spherule 0.0127 MG/ML Injectable SolutionSCD77108624-4771-4886-a3e2-b2625c444d1b24
1666441Coccidioides immitis spherule 1.27 MCG per 0.1 ML Injectable SolutionSY77108624-4771-4886-a3e2-b2625c444d1b24
1666446Spherusol 0.0127 MG/ML Injectable SolutionSY77108624-4771-4886-a3e2-b2625c444d1b24
1666446Spherusol 1.27 MCG per 0.1 ML Injectable SolutionSY77108624-4771-4886-a3e2-b2625c444d1b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59584-140-01595840140011 mL in 1 VIAL, MULTI-DOSE (59584-140-01) 1 ml2020-06-010000-00-00NoNoCurrent