Bludigo 8 mg/mL
Indigotindisulfonate Sodium · INJECTION · Sagent Pharmaceuticals
Bludigo is a injection containing indigotindisulfonate sodium at 8 mg/mL, taken intravenous. Manufactured by Sagent Pharmaceuticals.
Key Facts
- Brand Name
- Bludigo
- Generic Name
- Indigotindisulfonate Sodium
- NDC Code (Product)
25021-840- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 8 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216264
- Marketing Start
- 04/15/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose is 5 mL given intravenously over 1 minute. ( 2.1 ) Monitor blood pressure and heart rhythm during and after injection. ( 2.2 ) 2.1 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. 2.2 Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection [see Warnings and Precautions ( 5.1 )] . 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 Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration.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.
Contraindications
4 CONTRAINDICATIONS BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )] . Known hypersensitivity to indigotindisulfonate or any of its components. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial. A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously; 58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL. The 2.5 mL dose is not approved [see Dosage and Adm…
Frequently Asked Questions
What is Bludigo used for?
Bludigo contains Indigotindisulfonate Sodium. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Bludigo a controlled substance?
Bludigo is not classified as a controlled substance by the DEA.
What is the generic name for Bludigo?
The generic name for Bludigo is Indigotindisulfonate Sodium. There are 1 other brand versions of Indigotindisulfonate Sodium.
What is the NDC code for Bludigo 8 mg/mL?
The NDC (National Drug Code) for Bludigo 8 mg/mL is 25021-840, listed by Sagent Pharmaceuticals.