NDC 59584-140

Spherusol

Coccidioides Immitis Spherule-derived Skin Test Antigen

Spherusol is a Intradermal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nielsen Biosciences, Inc.. The primary component is Coccidioides Immitis Spherule.

• Product ID: 59584-140_1ed6fcd5-4d38-4d43-8941-c4d90e6733e2
• NDC: 59584-140
• Product Type: Human Prescription Drug
• Proprietary Name: Spherusol
• Generic Name: Coccidioides Immitis Spherule-derived Skin Test Antigen
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL
• Marketing Start Date: 2011-07-29
• Marketing Category: BLA / BLA
• Application Number: BLA125354
• Labeler Name: Nielsen BioSciences, Inc.
• Substance Name: COCCIDIOIDES IMMITIS SPHERULE
• Active Ingredient Strength: 13 ug/mL
• Pharm Classes: Skin Test Antigen [EPC],Cell-mediated Immunity [PE],Antigens, Fungal [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 59584-140-01

1 mL in 1 VIAL, MULTI-DOSE (59584-140-01)

• Marketing Start Date: 2020-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59584-140-01 [59584014001]

Spherusol INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125354
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-07-29

Drug Details

Active Ingredients

Ingredient	Strength
COCCIDIOIDES IMMITIS SPHERULE	12.7 ug/mL

OpenFDA Data

• SPL SET ID: 77108624-4771-4886-a3e2-b2625c444d1b
• Manufacturer:
  • Nielsen BioSciences, Inc.
• UNII:
  • ITY7G7Q744
• RxNorm Concept Unique ID - RxCUI:
  • 1666441
  • 1666446

Pharmacological Class

• Skin Test Antigen [EPC]
• Cell-mediated Immunity [PE]
• Antigens
• Fungal [CS]