Zyogreen

Indocyanine Green · Injection, Solution · Interstitial, Intravenous

Prescription (Rx)

Uses

1 INDICATIONS AND USAGE 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 ( 1.1 ) Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age 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 Tissue Perfusion ZYOGREEN is 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. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management. 1.4 Ophthalmic Angiography ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

Dosage and administration

Visualization of vessels, blood flow and tissue perfusion Pediatric patients less than 1 month of age: 0.15 mg/kg Adults and pediatric patients 1 month of age and older: 1.25 mg to 5 mg by intravenous injection ( 2.2 ) Extremity perfusion visualization through the skin Pediatric patients less than 1 month of age: 0.15 mg/kg Pediatric patients 1 month of age and older: 1.25 mg to 5 mg Adults: 3.75 mg to 10 mg by intravenous injection ( 2.2 ) Visualization of extrahepatic biliary ducts Pediatric patients from birth to less than 1 year of age: 0.1 mg/kg (not to exceed 2.5 mg) 12 to 24 hours prior to surgery Adults and pediatric patients 6 years of age and older: 2.5 mg by intravenous injection at least 45 minutes prior to surgery ( 2.3 ) Lymphatic mapping of cervical and uterine cancer in adults 5 mg interstitially as four 1.25 mg injections. See Full Prescribing Information for injection techniques. ( 2.4 ) Ophthalmic Angiography in adults and pediatric patients: doses up to 40 mg by intravenous injection. ( 2.5 ) The total dose must not exceed 2 mg/kg for all patients. 2.1 Important Administration Instructions ZYOGREEN is a ready-to-use solution, provided in ampules at a concentration of 2.5 mg per mL. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micrometer or smaller straw/filter needle to ensure that the withdrawn solution contains no particulates. Visually inspect the withdrawn solution for particulate matter and discoloration prior to administration. Each ampule of ZYOGREEN is for a single dose. Discard any unused portion. 2.2 Recommended Dose, Administration and Imaging for Visualization of Vessels, Blood Flow and Tissue Perfusion Dosing Administer the recommended initial dose of ZYOGREEN as a single intravenous injection. The recommended initial dose is based on patient age as shown in Table 1 . Additional doses may be administered to obtain imaging sequences during the procedure. The maximum total dose for any patient, including all initial and additional doses combined, must not exceed 2 mg/kg. Table 1. Recommended Dose of ZYOGREEN for Visualization of Vessels, Blood Flow and Tissue Perfusion by Age * Dose based on actual body weight Imaging Patient Age Recommended Dose Visualization of vessels, blood flow and tissue perfusion (single imaging sequence) Pediatric patients from birth to less than 1 month of age 0.15 mg/kg * Pediatric patients 1 month of age and older 1.25 mg to 5 mg Adults Extremity perfusion visualization through the skin (single imaging sequence) Pediatric patients from birth to less than 1 month of age 0.15 mg/kg * Pediatric patients 1 month of age and older 1.25 mg to 5 mg Adults 3.75 mg to 10 mg Administration Prior to the imaging procedure, draw the desired dose of ZYOGREEN into a syringe. For adults, prepare 10 mL of 0.9% Sodium Chloride Injection in a separate syringe for flushing. For pediatric patients, adjust the amount and type of flush for the individual patient to avoid volume and sodium overload. Administer via a central or peripheral venous line using a three-way stopcock. Inject ZYOGREEN as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush. Imaging Instructions Use ZYOGREEN with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of vessels, blood flow and tissue perfusion. A fluorescence response should be visible in blood vessels within 5 seconds to 15 seconds after injection. 2.3 Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts Dosing and Administration Administer the recommended dose of ZYOGREEN as a single intravenous injection. The initial dose and timing of administration are based on patient age as shown in Table 2 . Additional doses may be administered to obtain imaging sequences during the procedure. The maximum total dose for any patient, including all initial and additional doses combined, must not exceed 2 mg/kg. Table 2: Recommended Dose of ZYOGREEN for Visualization of Extrahepatic Biliary Ducts by Age * Dose based on actual body weight Patient Age Recommended Dose Timing of Administration Pediatric patients from birth to less than 1 year of age 0.1 mg/kg * (Do not exceed 2.5 mg) Administer 12 hours to 24 hours prior to surgery Pediatric patients from 1 to less than 6 years of age Not indicated Not applicable Pediatric patients 6 years of age and older 2.5 mg Administer at least 45 minutes prior to surgery Adults Imaging Instructions Use ZYOGREEN with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. For patients 6 years of age and older, fluorescence is visible in the biliary tree within 45 minutes after injection. For patients less than 1 year of age, fluorescence is visible in the biliary tree between 12 hours and 24 hours after injection. 2.4 Recommended Dose, Administration and Imaging for Lymphatic Mapping of Cervical and Uterine Cancer Dosing and Administration The recommended dose of ZYOGREEN for lymphatic mapping of cervical and uterine cancer in adults is 5 mg. Administer this dose interstitially as four separate 1.25 mg injections into the cervix, with each injection consisting of a 0.5 mL volume of the 2.5 mg/mL solution. The injections should be given at the 3 o'clock and the 9 o'clock positions of the cervix. At each of these two positions, one superficial injection (1 mm to 3 mm depth) and one deep injection (1 cm to 3 cm depth) are required to complete the dosing. Imaging Instructions Use ZYOGREEN with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of cervical and uterine cancer. Fluorescent lymphatic vessels and lymph nodes should begin to be visible within 1 minute after injection.

Dosage forms and strengths

Injection: 25 mg per 10 mL (2.5 mg per mL) of indocyanine green as a deep emerald-green ready-to-use solution in a single-dose ampule. Injection: 25 mg per 10 mL (2.5 mg per mL) of indocyanine green as a ready-to-use solution in a single-dose ampule ( 3 )

Contraindications

4 CONTRAINDICATIONS ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to indocyanine green ( 4 )

Warnings and precautions

Hypersensitivity reactions: Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green, the active ingredient in ZYOGREEN [see Adverse Reactions ( 6 )]. ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green [see Contraindications ( 4 )] . Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions. 5.2 Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration [see Drug Interactions ( 7 )].

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions have been identified during post-approval use of indocyanine green, the active ingredient in ZYOGREEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria. ( 6 ) 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 .

Drug interactions

Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of ZYOGREEN. ( 7 ) Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of ZYOGREEN.

Use in specific populations

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of ZYOGREEN in pregnant women. Available data from a very small number of scientific literature studies with indocyanine green use in pregnant women over several decades have not reported any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Data from one small study in which indocyanine green was administered intravenously to pregnant women during labor suggest there is no placental transfer of the drug. Animal reproduction studies have not been conducted with indocyanine green. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary Seventeen cases of indocyanine green use in lactating women have been reported in the scientific literature with no adverse events observed in the breastfed infant. However, there are no data on the presence of indocyanine green in human milk or the effects on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZYOGREEN and any potential adverse effects on the breastfed infant from ZYOGREEN or from the underlying maternal condition. 8.4 Pediatric Use Use in Pediatric Patients for Visualization of Vessels, Blood Flow and Tissue Perfusion The safety and effectiveness of ZYOGREEN 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 have been established in pediatric patients. Use of ZYOGREEN for this indication in pediatric patients is supported by evidence from clinical trials in adults and published studies that demonstrated the utility of indocyanine green for blood vessel evaluation and assessment of tissue perfusion in 59 pediatric patients, including 6 neonates, during surgeries within the indicated surgical categories. Use in Pediatric Patients for Visualization of Extrahepatic Biliary Ducts The safety and effectiveness of ZYOGREEN for fluorescence imaging of extrahepatic biliary ducts have been established in pediatric patients from birth to less than 1 year of age and in those 6 years of age and older. Use of ZYOGREEN for this indication in these age groups is supported by evidence from clinical trials in adults and from the following published studies in pediatric patients. For patients less than 1 year of age, supporting publications included two prospective observational studies and one retrospective case series evaluating a total of 34 pediatric patients (age range: 2 to 119 days) with jaundice undergoing Kasai portoenterostomy who received indocyanine green for fluorescence imaging of biliary structures. For patients 6 years of age and older, a supporting publication consisted of a prospective, single institution case series in 31 pediatric patients (age range: 6 to 18 years) undergoing cholangiography with indocyanine green during laparoscopic cholecystectomy. The safety and effectiveness of ZYOGREEN have not been established for fluorescence imaging of extrahepatic biliary ducts in pediatric patients 1 year to less than 6 years of age. Use in Pediatric Patients for Ophthalmic Angiography ZYOGREEN is indicated for ophthalmic angiography in pediatric patients. Use in Pediatric Patients for Lymphatic Mapping of Cervical and Uterine Cancer The safety and effectiveness of ZYOGREEN for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients. 8.5 Geriatric Use Of the total number of subjects in clinical studies of indocyanine green for visualization of vessels, blood flow and tissue perfusion, 7% were 65 and over, while 1% were 75 and over. Of the total number of subjects in clinical studies of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping of cervical and uterine cancer, 9% were 65 and over, while 2% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients. Clinical studies of indocyanine green for visualization of extrahepatic biliary ducts did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Pregnancy

Pediatric use

8.4 Pediatric Use Use in Pediatric Patients for Visualization of Vessels, Blood Flow and Tissue Perfusion The safety and effectiveness of ZYOGREEN 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 have been established in pediatric patients. Use of ZYOGREEN for this indication in pediatric patients is supported by evidence from clinical trials in adults and published studies that demonstrated the utility of indocyanine green for blood vessel evaluation and assessment of tissue perfusion in 59 pediatric patients, including 6 neonates, during surgeries within the indicated surgical categories. Use in Pediatric Patients for Visualization of Extrahepatic Biliary Ducts The safety and effectiveness of ZYOGREEN for fluorescence imaging of extrahepatic biliary ducts have been established in pediatric patients from birth to less than 1 year of age and in those 6 years of age and older. Use of ZYOGREEN for this indication in these age groups is supported by evidence from clinical trials in adults and from the following published studies in pediatric patients. For patients less than 1 year of age, supporting publications included two prospective observational studies and one retrospective case series evaluating a total of 34 pediatric patients (age range: 2 to 119 days) with jaundice undergoing Kasai portoenterostomy who received indocyanine green for fluorescence imaging of biliary structures. For patients 6 years of age and older, a supporting publication consisted of a prospective, single institution case series in 31 pediatric patients (age range: 6 to 18 years) undergoing cholangiography with indocyanine green during laparoscopic cholecystectomy. The safety and effectiveness of ZYOGREEN have not been established for fluorescence imaging of extrahepatic biliary ducts in pediatric patients 1 year to less than 6 years of age. Use in Pediatric Patients for Ophthalmic Angiography ZYOGREEN is indicated for ophthalmic angiography in pediatric patients. Use in Pediatric Patients for Lymphatic Mapping of Cervical and Uterine Cancer The safety and effectiveness of ZYOGREEN for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients.

Geriatric use

8.5 Geriatric Use Of the total number of subjects in clinical studies of indocyanine green for visualization of vessels, blood flow and tissue perfusion, 7% were 65 and over, while 1% were 75 and over. Of the total number of subjects in clinical studies of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping of cervical and uterine cancer, 9% were 65 and over, while 2% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients. Clinical studies of indocyanine green for visualization of extrahepatic biliary ducts did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Description

(indocyanine green injection) is an optical imaging agent for intravenous or interstitial use. The chemical name for indocyanine green is 1 H- Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2 H -benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. It has a molecular formula of C 43 H 47 N 2 NaO 6 S 2 and a molecular mass of 774.96 g/mol. The structural formula is shown below. Indocyanine green has a peak spectral absorption at 805 nm in blood. ZYOGREEN is a sterile, ready-to-use solution. Each mL contains 2.5 mg of indocyanine green with not more than 0.125 mg sodium iodide and the following inactive ingredients: 1 mg sodium ascorbate and water for injection with a pH between 5.5 and 7.5. structural formula

Mechanism of action

12.1 Mechanism of Action When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near infrared light for indocyanine green to absorb, resulting in excitation of the indocyanine green, and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor. These optical properties of indocyanine green are utilized in fluorescence imaging of the micro- and macro- vasculature, blood flow and tissue perfusion, the extrahepatic biliary ducts, and for lymphatic mapping of lymph nodes and lymphatic vessels.

How supplied

How Supplied ZYOGREEN (Indocyanine Green Injection), is a deep emerald-green ready-to-use solution in amber glass ampules supplied as follows: NDC ZYOGREEN ® (Indocyanine Green Injection) (2.5 mg per mL) Package Factor 25021-841-10 25 mg per 10 mL Single-Dose Ampules 5 ampules per carton Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store in original carton to protect from light. Do not refrigerate or freeze. Use immediately after opening ampule. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. Not made with natural rubber latex.

Patient information

Hypersensitivity Reactions Advise patients to seek medical attention for reactions following injection of ZYOGREEN such as difficulty breathing, swollen tongue or throat, skin reactions including hives, itching and flushed or pale skin, low blood pressure, a weak and rapid pulse and other symptoms or signs of an anaphylactic reaction [see Warnings and Precautions ( 5.1 )] . sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in France ©2026 Sagent Pharmaceuticals June 2026

Label text from the FDA structured product label by Sagent Pharmaceuticals (revised Jul 16, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Indocyanine Green in 1 product

Zyogreen NDC products (1)

NDC	Strength & form	Labeler	Type
25021-841	Indocyanine Green 2.5 mg/mL Injection, Solution	Sagent Pharmaceuticals	NDA

Frequently asked questions

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Who makes Zyogreen?

Zyogreen is listed by 1 labeler in the FDA NDC directory, including Sagent Pharmaceuticals.