Medicine
Tubersol 5 IU/0.1 mL injection
Tubersol 5 IU/0.1 mL injection is a prescription medicine containing Tuberculin purified protein derivative for intradermal use, marketed by Sanofi Vaccines, 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 at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if exposed to…
Key facts
- Active ingredient (INN)
- Tuberculin purified protein derivative
- Brand
- Tubersol
- Strength
- 5 IU/0.1 mL
- Dosage form
- Injection
- Route
- Intradermal
- Packs
- 1 vial and 1 more
- Marketing authorisation holder
- Sanofi Vaccines
- Manufacturers
- Sanofi VaccinesA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Store at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if exposed to freezing. Protect from light. The product should be stored in the dark except when doses are actually being withdrawn from the vial.
- 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
- 15 August 1956
- Identifiers
- RxCUI 313532, 798415DailyMed set ID a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd, 261efc52-a105-4c2c-a8ce-9eee20b62efc, ca1199eb-2f86-4e27-967b-fb1c814dafd2NDC 49281-752, 50090-0261, 50090-1668Application BLA103941
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 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 49281-752-21 | Sanofi Vaccines | 15 August 1956 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 49281-752-22 | Sanofi Vaccines | 15 August 1956 |
| 1 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 50090-0261-0 | A-S Medication Solutions | 29 June 2016 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 50090-1668-0 | A-S Medication Solutions | 28 January 2015 |
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
Alternatives
Other makers and brands of Tuberculin purified protein derivative 5 IU/0.1 mL injection.
Clinical summary
Tuberculin purified protein derivative is a skin test antigen indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. It is available as injection for intradermal use. MedsAcross supplies Tuberculin purified protein derivative 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 Tuberculin purified protein derivativeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TUBERSOL prescribing information (Sanofi Vaccines) · U.S. National Library of Medicine, DailyMed
Need Tubersol 5 IU/0.1 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.