Medicine
Isosulfan blue 50 mg/5 mL injection
Isosulfan blue 50 mg/5 mL injection is a generic prescription medicine for subcutaneous use, made by 6 labelers, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Isosulfan blue
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 6 vials of 5 mL, 1 vial of 5 mL and 5 more
- Manufacturers
- EugiaIndiaNovadoz PharmaceuticalsIndiaDevatisMeitheal PharmaceuticalsMylan InstitutionalSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 March 2013
- Identifiers
- DailyMed set ID 42f2d62a-c7f2-4706-87bc-64f3e72d63a9, d36ae5af-6351-497a-9151-82bcb2c62fa0, aa6260da-0acd-4552-a215-07df8da1031c +4NDC 55150-240, 71288-805, 73043-093 +3Application ANDA206831, ANDA213130, ANDA210714 +3
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 6 vial in 1 carton / 5 mL in 1 vial | 55150-240-05 | EugiaIndia | 2 February 2016 |
| 6 vial in 1 carton / 5 mL in 1 vial | 55150-240-06 | EugiaIndia | 2 February 2016 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 72205-195-01 | Novadoz PharmaceuticalsIndia | 30 June 2026 |
| 6 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 72205-195-02 | Novadoz PharmaceuticalsIndia | 30 June 2026 |
| 6 vial, glass in 1 carton / 5 mL in 1 vial, glass | 73043-093-06 | Devatis | 30 June 2026 |
| 6 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 71288-805-06 | Meitheal Pharmaceuticals | 3 November 2021 |
| 6 vial, glass in 1 carton / 5 mL in 1 vial, glass | 67457-220-05 | Mylan Institutional | 14 March 2013 |
| 6 vial in 1 carton / 5 mL in 1 vial | 70069-221-06 | Somerset Therapeutics | 30 June 2026 |
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 |
| US FDA | First approved 29 July 1981 | Drugs@FDA |
| 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
Other strengths and forms of Isosulfan blue
Clinical summary
Isosulfan blue is a prescription medicine. It is available as injection for subcutaneous use. MedsAcross supplies Isosulfan blue 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 Isosulfan blueFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Isosulfan Blue prescribing information (Devatis) · U.S. National Library of Medicine, DailyMed
Need Isosulfan blue 50 mg/5 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.