Prescription medicine
Indocyanine green and water
Indocyanine green and water is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the indocyanine green and water FDA label on DailyMed (effective April 13, 2025, Renew Pharmaceuticals Limited); every indocyanine green and water label on DailyMed.
Highlights of the record
FDA label of April 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIndocyanine Green for injection is indicated: Indocyanine Green for injection is an optical imaging agent indicated for:
Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric pa
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
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
- 103 through July 30, 2026
What is indocyanine green and water used for?
From the label: indications and usageIndocyanine Green for injection is indicated: Indocyanine Green for injection is an optical imaging agent indicated for:
Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 )
Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 )
Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine […]
Source: FDA drug label (Indocyanine Green), Renew Pharmaceuticals Limited, effective April 13, 2025 (SPL set a6f24787-c243-445a-9c55-7c7479b292d9), via openFDA; the full label on DailyMed
Is there a generic for indocyanine green and water?
No generic indocyanine green and water is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists indocyanine green and water from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for indocyanine green and water?
The FDA Adverse Event Reporting System holds 103 reports that list indocyanine green and water among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 24 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?
- Indocyanine green and water side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other