Prescription medicine
Indocyanine green Brand names: Ic-Green, Zyogreen
Indocyanine green (Ic-Green) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the indocyanine green FDA label on DailyMed (effective January 30, 2026, Renew Pharmaceuticals Limited); the NDA 11525 record on Drugs@FDA; every indocyanine green label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFluorescence 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
Forms and strengths
- 2.5 mg/ml
Kit; injection (solution).
On the market
- Earliest approval on file
- February 9, 1959 Ic-Green, Renew Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first November 21, 2007; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 14, 2039 Spy Agent Green Kit 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)
- 0 since 2012 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 116 through July 30, 2026
What is indocyanine green used for?
From the label: indications and usageFluorescence 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 cancer ( 1.3 )
Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and […]
FDA pharmacologic class: Diagnostic Dye.
Source: FDA drug label (IC-Green), Renew Pharmaceuticals Limited, effective January 30, 2026 (SPL set ccd92843-1f0a-4ece-9978-4b300d158886), via openFDA; the full label on DailyMed
Is there a generic for indocyanine green (Ic-Green)?
The FDA approved the first generic indocyanine green on November 21, 2007. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists indocyanine green from 2 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ic-Green injection; a patent listed only for Spy Agent Green Kit injection runs to July 14, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1959 earliest approval on file
- 2007 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has indocyanine green been recalled?
The FDA's Enforcement Report lists 2 recalls naming indocyanine green since 2012: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of indocyanine green and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 21, 2016 | Class II | Wells Pharmacy Network LLC not a listed maker | Lack of Assurance of Sterility |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for indocyanine green?
The FDA Adverse Event Reporting System holds 116 reports that list indocyanine green 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?
- Other diagnostic dyes
- the pharmacologic class, with prices and generics
- Indocyanine green side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other