Home NDC 59584-140-01 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59584-140 59584-140-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 59584-140 59584-140-01 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 59584-140 59584-140-01 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…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 Ingredient Strength COCCIDIOIDES IMMITIS SPHERULE 12.7 ug/mL
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59584-140-01 Spherusol 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 1 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COCCIDIOIDES IMMITIS SPHERULE ACTIVE INGREDIENT ITY7G7Q744 SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5 COCCIDIOIDES IMMITIS SPHERULE ACTIVE MOIETY ITY7G7Q744 SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5 PHENOL INACTIVE INGREDIENT 339NCG44TV SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59584-140 SPHERUSOL (COCCIDIOIDES IMMITIS SPHERULE-DERIVED SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 24 Current NDC, Legacy NDC, 1 package rows 20250116_77108624-4771-4886-a3e2-b2625c444d1b.zip
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125354 Spherusol Coccidioides immitis Spherule-Derived Skin Test Antigen 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59584-140-01 59584014001 1 mL in 1 VIAL, MULTI-DOSE (59584-140-01) 1 ml 2020-06-01 0000-00-00 No No Current