Medicine
Bludigo 40 mg/5 mL injection
Bludigo 40 mg/5 mL injection is a prescription medicine containing Indigotindisulfonate for intravenous use, marketed by Provepharm, 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
Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Indigotindisulfonate
- Brand
- Bludigo
- Strength
- 40 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 ampules of 5 mL
- Marketing authorisation holder
- Provepharm
- Manufacturers
- ProvepharmSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59° to 86°F). Store in original carton to protect from light.
- 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
- 6 September 2022
- Identifiers
- DailyMed set ID 73f246c4-b127-452e-856f-134b56cb8870, 2b91c39d-5f15-4dcf-9d3d-b378470e6bd7NDC 81284-315, 25021-840Application NDA216264
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 |
|---|---|---|---|
| 5 ampule in 1 carton / 5 mL in 1 ampule | 81284-315-05 | Provepharm | 6 September 2022 |
| 5 ampule in 1 carton / 5 mL in 1 ampule | 25021-840-05 | Sagent Pharmaceuticals | 15 April 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 8 July 2022 | 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
Clinical summary
Indigotindisulfonate is a diagnostic dye indicated as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. MedsAcross supplies Indigotindisulfonate 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 IndigotindisulfonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bludigo prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bludigo 40 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.