Quick answers
- What is Indocyanine green used for?
- The FDA-approved label (Zyogreen, Sagent Pharmaceuticals, July 16, 2026) says: “ZYOGREEN 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 Fluorescence imaging of extrahepatic biliary ducts in adults …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Indocyanine green have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Indocyanine green?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Indocyanine green been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Indocyanine green?
- 1 company lists prescription products of Indocyanine green in the FDA NDC Directory, including Sagent Pharmaceuticals.
What Indocyanine green is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZYOGREEN 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 Fluorescence imaging of extrahepatic biliary ducts in adults …
— FDA label: Zyogreen, Sagent Pharmaceuticals, effective July 16, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Interstitial · Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Zyogreen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sagent Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218579 ZYOGREEN | Provepharm Sas | July 10, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | b2de0c9a-0065-4f2c-9983-add39525f3a3 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA218579 |
| Active ingredients (FDA) | INDOCYANINE GREEN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zyogreen, Sagent Pharmaceuticals, effective July 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →