Molecule
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
From the regulator-approved product information. Each section names its source.
BLUDIGO is indicated for use 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. BLUDIGO is a diagnostic dye indicated for use 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.
Source: US FDA prescribing information
Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.
Source: US FDA prescribing information
Recommended dose is 5 mL given intravenously over 1 minute. Monitor blood pressure and heart rhythm during and after injection. Recommended Dosage The recommended dose of BLUDIGO is 5 mL given as an intravenous injection over 1 minute. The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection. Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion.
Source: US FDA prescribing information
BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components. Known hypersensitivity to indigotindisulfonate or any of its components.
Source: US FDA prescribing information
Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO injection. Interrupt administration if reactions are observed. Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO.
Source: US FDA prescribing information
Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions Hypersensitivity Reactions Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59° to 86°F). Do not refrigerate or freeze. Store in original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Indigotindisulfonate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Bludigo 40 mg/5 mL injectionIntravenous | Provepharm | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| 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 |
Yes, on request. MedsAcross lists 1 presentations of Indigotindisulfonate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Indigotindisulfonate, including Bludigo.
Yes. The US FDA first approved Indigotindisulfonate on 8 July 2022, according to Drugs@FDA.
No listed presentation of Indigotindisulfonate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.