Prescription medicine
Indigotindisulfonate Brand names: Bludigo
Indigotindisulfonate (Bludigo) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the indigotindisulfonate FDA label on DailyMed (effective November 11, 2025, Provepharm Inc.); the NDA 216264 record on Drugs@FDA; every indigotindisulfonate label on DailyMed.
Highlights of the record
FDA label of November 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBLUDIGO 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.
Forms and strengths
- 8 mg/ml
Injection.
On the market
- Earliest approval on file
- July 8, 2022 Bludigo, Provepharm Sas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- December 23, 2037 Bludigo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4 through July 30, 2026
What is indigotindisulfonate used for?
From the label: indications and usageBLUDIGO 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.
FDA pharmacologic class: Diagnostic Dye.
Source: FDA drug label (BLUDIGO), Provepharm Inc., effective November 11, 2025 (SPL set 73f246c4-b127-452e-856f-134b56cb8870), via openFDA; the full label on DailyMed
Is there a generic for indigotindisulfonate (Bludigo)?
No generic indigotindisulfonate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Bludigo injection: the compound patent runs to December 23, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the indigotindisulfonate label say about other medicines?
The indigotindisulfonate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Nitric oxide | warnings and precautions | Indigotindisulfonate may cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction. |
Source: FDA drug label (BLUDIGO), Provepharm Inc., effective November 11, 2025 (SPL set 73f246c4-b127-452e-856f-134b56cb8870), via openFDA; the full label on DailyMed
What do FAERS reports show for indigotindisulfonate?
The FDA Adverse Event Reporting System holds 4 reports that list indigotindisulfonate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other diagnostic dyes
- the pharmacologic class, with prices and generics
- Indigotindisulfonate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other