Indocyanine Green
Kit
Uses
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 cancer ( 1.3 ) Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion Indocyanine green for injection 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 aged 1 month and older. 1.2 Visualization of Extrahepatic Biliary Ducts Indocyanine green for injection is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer Indocyanine green for injection 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 Indocyanine green for injection is indicated for use in ophthalmic angiography in adults and pediatric patients.
Dosage and administration
Visualization of vessels, blood flow and tissue perfusion (2.5 mg/mL solution) 1.25 mg to 5 mg by intravenous injection is recommended for a surgical procedure in adults and pediatric patients aged 1 month and older. 3.75 mg to 10 mg by intravenous injection is recommended for visualization of perfusion in extremities through the skin for plastic, micro- and reconstructive surgeries in adults. Additional doses may be administered. Do not exceed a total dose of 2 mg/kg. ( 2.1 ) Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older (2.5 mg/mL solution) 2.5 mg by intravenous injection at least 45 minutes prior to surgery. Additional doses may be administered. Do not exceed a total dose of 2 mg/kg. ( 2.2 ) Lymphatic mapping of cervical and uterine cancer in adults (1.25 mg/mL solution) 5 mg interstitially as four 1 mL injections. See Full Prescribing Information for injection techniques. ( 2.3 ) Ophthalmic Angiography Doses up to 40 mg in 2 mL of Sterile Water for Injection by intravenous injection. ( 2.4 ) See Full Prescribing Information for reconstitution instructions. ( 2.5 ). 2.1 Recommended Dose, Administration and Imaging for Visualization of Vessels, Blood Flow and Tissue Perfusion Dosing Adults: The recommended dose of indocyanine green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in adults is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. For visualization of perfusion in extremities through the skin in adults, the recommended dose is 3.75 mg to 10 mg administered intravenously as 1.5 mL to 4 mL of a 2.5 mg/mL solution. Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride Injection. Pediatric patients aged 1 month and older The recommended dose of indocyanine green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in pediatric patients aged 1 month and older is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. Lower doses may be administered in younger patients and in those with lower body weight. Adjust the amount and type of flush to avoid volume and/or sodium overload. In both adults and pediatric patients aged 1 month and older, additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg. Administration Prior to the imaging procedure, draw up the desired dose of indocyanine green solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride Injection. Administer via a central or peripheral venous line using a three-way stopcock attached to an injection port on the infusion line. Inject the prepared indocyanine green into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush. Imaging Instructions Indocyanine green may be used 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. 2.2 Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts Dosing and Administration The recommended dose of indocyanine green for visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older is 2.5 mg administered intravenously as 1 mL of a 2.5 mg/mL solution at least 45 minutes prior to surgery. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed a total dose of 2 mg/kg. Imaging Instructions Indocyanine green may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. Fluorescence is visible in the biliary tree within 45 minutes after injection. 2.3 Recommended Dose, Administration and Imaging for Lymphatic Mapping of Cervical and Uterine Cancer Dosing and Administration The recommended dose of indocyanine green for lymphatic mapping of cervical and uterine cancer in adults is 5 mg administered interstitially as four 1 mL injections of a 1.25 mg/mL solution into the cervix, at the 3 o' clock and the 9 o'clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 3 cm) injection at each position. Imaging Instructions Indocyanine green may be used 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. 2.4 Recommended Dose and Administration for Ophthalmic Angiography Dosing and Administration Doses up to 40 mg indocyanine green in 2 mL of Sterile Water for Injection depending on the imaging equipment and technique used should be administered intravenously and immediately followed by a 5 mL bolus of 0.9% Sodium Chloride Injection. The antecubital vein can be used for indocyanine green administration. 2.5 Reconstitution Instructions General Prepare indocyanine green using aseptic techniques prior to procedure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect the reconstituted solution for particulate matter. The reconstituted solution should be a clear, green solution. Use the prepared solution within 6 hours. Discard any unused product. Visualization of Vessels, Blood Flow, Tissue Perfusion and Extrahepatic Biliary Ducts Dissolve 25 mg of indocyanine green with 10 mL Sterile Water for Injection to form a concentration of 2.5 mg/mL indocyanine green.
Dosage forms and strengths
For injection: 25 mg of indocyanine green as a sterile, lyophilized, dark green, blue-green, dark blue, olive-brown or black color cake or powder for reconstitution provided in a 20 mL single-patient-use vial. For injection: 25 mg of indocyanine green as a lyophilized, dark green, blue-green, dark blue, olive-brown or black color cake or powder for reconstitution in a single-patient-use vial ( 3 )
Contraindications
Indocyanine green 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: Hypersensitivity reactions including anaphylaxis and urticaria have occurred. 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 [see Adverse Reactions ( 6 )]. Indocyanine green 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 indocyanine green 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. 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www fda.gov/medwatch.
Drug interactions
Interference with Thyroid Radioactive Iodine Uptake Studies Because indocyanine green 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 indocyanine green. Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of indocyanine green. ( 7 )
Use in specific populations
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of indocyanine green 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 indocyanine green and any potential adverse effects on the breastfed infant from indocyanine green or from the underlying maternal condition. 8.4 Pediatric Use Use of indocyanine green for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients aged 1 month and older. Pediatric use is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro- and reconstructive surgical procedures and by clinical trials in adults . No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.1 )]. The use of indocyanine green for visualization of vessels, blood flow and tissue perfusion has not been established in pediatric patients aged less than 1 month. Use of indocyanine green for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 years and older. Pediatric use is supported by clinical trials in adults in addition to clinical use in pediatric patients. No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.2 )] . The use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients aged less than 12 years. Use of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients. Use of indocyanine green for ophthalmic angiography has been established in pediatric patients. Pediatric use is supported by evidence from the published literature. 8.5 Geriatric Use Of the total number of patients in clinical studies of indocyanine green for injection 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 patients in clinical studies of indocyanine green for injection 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. Clinical studies of indocyanine green for injection for visualization of extrahepatic biliary ducts did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified differences in responses between elderly and younger patients. 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
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of indocyanine green 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.
Pediatric use
8.4 Pediatric Use Use of indocyanine green for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients aged 1 month and older. Pediatric use is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro- and reconstructive surgical procedures and by clinical trials in adults . No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.1 )]. The use of indocyanine green for visualization of vessels, blood flow and tissue perfusion has not been established in pediatric patients aged less than 1 month. Use of indocyanine green for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 years and older. Pediatric use is supported by clinical trials in adults in addition to clinical use in pediatric patients. No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.2 )] . The use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients aged less than 12 years. Use of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients. Use of indocyanine green for ophthalmic angiography has been established in pediatric patients. Pediatric use is supported by evidence from the published literature.
Geriatric use
8.5 Geriatric Use Of the total number of patients in clinical studies of indocyanine green for injection 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 patients in clinical studies of indocyanine green for injection 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. Clinical studies of indocyanine green for injection for visualization of extrahepatic biliary ducts did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified differences in responses between elderly and younger patients. 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 for injection, USP is an optical imaging agent for intravenous or interstitial use. Each vial contains 25 mg of indocyanine green, USP with not more than 5% sodium iodide and sodium hydroxide (pH adjuster) as a sterile, lyophilized, dark green, blue-green, dark blue, olive-brown or black color cake or powder. Indocyanine green has a pH of 5.5-7.5 when reconstituted with Sterile Water for Injection, USP. 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. The molecular formula is C 43 H 47 N 2 NaO 6 S 2 . The molecular weight is 774.96 g/mol and the chemical structure is: Indocyanine green has a peak spectral absorption at 805 nm in blood. Image
How supplied
How Supplied Indocyanine green for injection, USP is supplied as a kit (NDC 70710-2018-3) containing the following: Six 20 mL single-patient-use vials of indocyanine green for injection, USP (25 mg each) as a sterile, lyophilized, dark green, blue-green, dark blue, olive-brown or black color cake or powder for reconstitution NDC 70710-2031-1 Carton (NDC 70710-2032-8) containing six single-dose vials (NDC 70710-2032-1) of Sterile Water for Injection, USP (10 mL each) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]
Patient information
Hypersensitivity Reactions Advise patients to seek medical attention for reactions following injection of indocyanine green 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 )] .
Label text from the FDA structured product label by Zydus Pharmaceuticals USA Inc. (revised Aug 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Indocyanine Green NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 73624-424 | Kit | Olympus America, Inc. | ANDA |
| 70100-424 | Kit | Renew Pharmaceuticals Limited | ANDA |
| 70771-1961 | Kit | Zydus Lifesciences Limited | ANDA |
| 70710-2018 | Kit | Zydus Pharmaceuticals USA Inc. | ANDA |
Frequently asked questions
What is Indocyanine Green used for?
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…
What are the side effects of Indocyanine Green?
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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate… See the full label for the complete list.
Who makes Indocyanine Green?
Indocyanine Green is listed by 4 labelers in the FDA NDC directory, including Olympus America, Inc., Renew Pharmaceuticals Limited, Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc..