Medicine
Spherusol 12.7 mcg/1 mL injection
Spherusol 12.7 mcg/1 mL injection is a prescription medicine containing Coccidioides immitis spherule for intradermal use, marketed by Nielsen BioSciences, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated at 2° to 8°C (35° to 46°F). Do not freeze.
Key facts
- Active ingredient (INN)
- Coccidioides immitis spherule
- Brand
- Spherusol
- Strength
- 12.7 mcg/1 mL
- Dosage form
- Injection
- Route
- Intradermal
- Packs
- 1 mL
- Marketing authorisation holder
- Nielsen BioSciences
- Manufacturer
- Nielsen BioSciences
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2° to 8°C (35° to 46°F). Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 July 2011
- Identifiers
- RxCUI 1666441, 1666446DailyMed set ID 77108624-4771-4886-a3e2-b2625c444d1bNDC 59584-140Application BLA125354
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 mL in 1 vial, multi-dose | 59584-140-01 | Nielsen BioSciences | 1 June 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Coccidioides immitis spherule is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis. It is available as injection for intradermal use. MedsAcross supplies Coccidioides immitis spherule for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Coccidioides immitis spheruleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Spherusol prescribing information (Nielsen BioSciences) · U.S. National Library of Medicine, DailyMed
Need Spherusol 12.7 mcg/1 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.