{"id":"indocyanine-green","rwe":[],"_fda":{"id":"e6cdd6c3-3611-4ced-9cd6-6642718999de","set_id":"91c206e8-fab9-4bf3-afcf-304eddf0d54e","openfda":{"upc":["0370100424014"],"spl_id":["e6cdd6c3-3611-4ced-9cd6-6642718999de"],"brand_name":["Indocyanine Green"],"spl_set_id":["91c206e8-fab9-4bf3-afcf-304eddf0d54e"],"package_ndc":["73624-424-02","0409-4887-17"],"product_ndc":["73624-424"],"generic_name":["INDOCYANINE GREEN AND WATER"],"product_type":["HUMAN PRESCRIPTION DRUG"],"manufacturer_name":["Olympus America, Inc."],"application_number":["ANDA040811"],"is_original_packager":[true]},"version":"2","pregnancy":["8.1 Pregnancy Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated."],"overdosage":["10 OVERDOSAGE There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after intravenous administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits. Based on body surface area, these doses are 2.4 to 13-fold the maximum recommended human (MRHD) dose of 2 mg/kg for indicator-dilution studies, 10 to 52-fold the MRHD of 0.5 mg/kg for hepatic-function studies, and 7 to 39-fold the MRHD of 0.67 mg/kg for ophthalmic angiography studies."],"description":["11 DESCRIPTION Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP used to dissolve the indocyanine green. Indocyanine Green for Injection USP is to be administered intravenously. Indocyanine green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm. 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. Indocyanine Green for Injection USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection USP contains 25 mg of indocyanine green as a sterile lyophilized powder. Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Indocyanine Green for Injection USP is supplied in a kit (NDC 73624-424-02) containing six 25 mg Indocyanine Green for Injection USP vials and six 10 mL Sterile Water for Injection, USP plastic vials: NDC 70100-424-01 Indocyanine Green for Injection USP vial. 25 mg fill in 25 mL vial. NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection, USP, 10 mL fill in 10 mL plastic vials. STORAGE: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]."],"geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of indocyanine green for visual assessment of blood vessels, blood flow and related tissue perfusion, for visual assessment of the major extrahepatic bile duct and for intra-operative blood flow in the cerebral area using this IR imaging application has not been evaluated in pediatric patients."],"effective_time":"20200601","nursing_mothers":["8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indocyanine Green for Injection USP is administered to a nursing woman."],"adverse_reactions":["6 ADVERSE REACTIONS Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids. Most common adverse reactions are anaphylactic or urticarial reactions. These have been reported in patients with and without a history of allergy to iodides. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@ diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Preparations containing sodium bisulfite including some heparin products reduce the absorption peak of Indocyanine Green for Injection USP in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis. Products containing sodium bisulfite reduce the absorption peak of Indocyanine Green for Injection USP in blood. ( 7 )"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY Indocyanine Green for Injection USP permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. Following intravenous injection, Indocyanine Green for Injection USP is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). Indocyanine Green for Injection USP undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green for Injection USP is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green for Injection USP a helpful index of hepatic function. The peak absorption and emission of Indocyanine Green for Injection USP lie in a region (800 to 850 nm) where transmission of energy by the pigment epithelium is more efficient than in the region of visible light energy. Indocyanine Green for Injection USP also has the property of being nearly 98% bound to blood protein, and therefore, excessive dye extravasation does not take place in the highly fenestrated choroidal vasculature. It is, therefore, useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera. The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be significantly greater in women than in men, although there was no significant difference in the calculated value for clearance."],"indications_and_usage":["1 INDICATIONS AND USAGE Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system ( 1.1 ) • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system ( 1.2 ) • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system ( 1.3 ) 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system 1.2 Visual assessment of the major extrahepatic bile duct For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system. 1.3 Viewing intra-operative blood flow in the cerebral area For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization. ( 5.1 ) • Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. ( 5.2 ) • Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP. ( 5.3 ) 5.1 Anaphylaxis Deaths from anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization. 5.2 Drug Instability Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the dilution curves. If a precipitate is present, discard the solution. 5.3 Drug/Laboratory Test Interactions Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility."],"spl_unclassified_section":["Manufactured by: Patheon Italia S.p.A. 20900 Monza (MB), ITALY Distributed by: OLYMPUS AMERICA INC. 3500 Corporate Parkway P.O. Box 610 Center Valley, PA, 18034-0610 Sterile Water for Injection, USP is manufactured by: Fresenius Kabi USA, LLC Grand Island, NY 14072 USA or Hospira, Inc. Rocky Mount, NC 27804 USA 50652 06/2020"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION For visual assessment of blood vessels, blood flow and related tissue perfusion ( 2.1 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 0.1 mg/kg (0.04 mL/kg) – 0.3 mg/kg (0.12 mL/kg). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline immediately before IR imaging. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. For visual assessment of the major extrahepatic bile ducts ( 2.2 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 3.0 mg (1.2 mL). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline at least 30 minutes prior to IR imaging. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. For viewing intra-operative blood flow in the cerebral area ( 2.3 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 0.1 mg/kg (0.04 mL/kg) – 0.3 mg/kg (0.12 mL/kg). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline immediately before IR imaging Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. 2.1 Visual assessment of blood vessels, blood flow and related tissue perfusion Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated immediately before IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus injection. Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline. 2.2 Visual assessment of the major extrahepatic bile duct Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The dosage for one administration should be 3.0 mg (1.2 mL) per patient. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated at least 30 minutes prior to IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with 3.0 mg (1.2 mL) of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus. At least 30 minutes prior to IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline. 2.3 Viewing intra-operative blood flow in the cerebral area Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated immediately before IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus. Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline."],"spl_product_data_elements":["Indocyanine Green Indocyanine Green and Water Indocyanine Green Indocyanine Green INDOCYANINE GREEN INDOCYANINE GREEN ACID FORM SODIUM IODIDE Sterile Water Water WATER WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indocyanine Green for Injection USP is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of indocyanine green for visual assessment of blood vessels, blood flow and related tissue perfusion, for visual assessment of the major extrahepatic bile duct and for intra-operative blood flow in the cerebral area using this IR imaging application has not been evaluated in pediatric patients. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients."],"dosage_and_administration_table":["
Item Note
Indocyanine Green for Injection, USP25 mg vials of ICG powder
Sterile Water for Injection (for dissolving ICG)10 mL vial of sterile water
Syringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mL
Syringes (for each administration)Considering the administration volume, select the appropriate size
Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration
Syringes (for each saline flush)Use the syringe whose minimum volume is 12 mL
","
Item Note
Indocyanine Green for Injection, USP25 mg vials of ICG powder
Sterile Water for Injection (for dissolving ICG)10 mL vial of sterile water
Syringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mL
Syringes (for each administration)Considering the administration volume, select the appropriate size
Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration
Syringes (for each saline flush)Use the syringe whose minimum volume is 12 mL
","
Item Note
Indocyanine Green for Injection, USP25 mg vials of ICG powder
Sterile Water for Injection (for dissolving ICG)10 mL vial of sterile water
Syringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mL
Syringes (for each administration)Considering the administration volume, select the appropriate size
Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration
Syringes (for each saline flush)Use the syringe whose minimum volume is 12 mL
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Carton Label Carton Label NDC 73624-424-02 Indocyanine Green for Injection, USP For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile Distributed by: OLYMPUS AMERICA INC. Back Panel NDC 73624-424-02 DIRECTIONS FOR USE ENCLOSED CAUTION: To ensure accurate readings, Indocyanine Green, USP dissolved in Sterile Water for Injection, USP must be used within 6 hours. STORAGE: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. USAGE: See package insert for dosage information. Contents: Six Indocyanine Green for Injection, USP vials (25 mg each) Six Sterile Water for Injection, USP Vials (10 mL each) Indocyanine Green for Injection, USP For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile Right Panel Indocyanine Green for Injection, USP Distributed by: OLYMPUS AMERICA INC. 3500 Corporate Parkway, P.O. Box 610, Center Valley, PA 1834-0610, U.S.A. Manufactured by: Patheon Italia S.p.A. 20900 Monza (Milano) ITALY Sterile Water Manufactured by: Hospira, Inc. Rocky Mount, NC 27804 or Fresenius Kabi USA, LLC Grand Island, NY 14072 4/2020 Principal Display Panel - Carton Label","PRINCIPAL DISPLAY PANEL - Vial Label Vial Label NDC 70100-424-01 Indocyanine Green for Injection, USP 25 mg/Vial Single-Patient-Use After reconstitution, use within 6 hours. Rx only Sterile Distributed by: Diagnostic Green LLC 50428 04/2022 Lot No. Exp.: Principal Display Panel - Vial Label","PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL Sterile Water Label 10 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE LOT ##-###-AA EXP DMMMYYYY Rx only NDC 0409-4887-17 Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Do not give intravenously unless rendered nearly isotonic. Distributed by RL-7603 Hospira, Inc., Lake Forest, IL 60045 USA Principal Display Panel - Sterile Water"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility."]},"tags":[{"label":"Diagnostic Dye","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V04CX01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Evaluation of vascular and tissue blood flow","category":"indication"},{"label":"Sentinel lymph node mapping in breast cancer","category":"indication"},{"label":"Sentinel lymph node mapping in malignant melanoma","category":"indication"},{"label":"Renew Pharms","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Coloring Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":82.792,"date":"","count":11,"signal":"Haemangioma congenital","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=83)"}],"commonSideEffects":[{"effect":"Anaphylactic or urticarial reactions","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"Teratogenic Effects: Pregnancy Category C: Animal Reproduction studies have not been conducted with Indocyanine Green. It is also not known whether Indocyanine Green can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Indocyanine Green should be given to pregnant woman only if clearly indicated.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have been established."}},"trials":[],"aliases":[],"company":"Renew Pharms","patents":[{"type":"Method of Use","number":"8647605","applicant":"NOVADAQ TECHNOLOGIES ULC","territory":"US","tradeName":"SPY AGENT GREEN KIT","expiryDate":"2029-02-11"},{"type":"Method of Use","number":"8406860","applicant":"NOVADAQ TECHNOLOGIES ULC","territory":"US","tradeName":"SPY AGENT GREEN KIT","expiryDate":"2029-04-09"},{"type":"Method of Use","number":"8185176","applicant":"NOVADAQ TECHNOLOGIES ULC","territory":"US","tradeName":"SPY AGENT GREEN KIT","expiryDate":"2028-06-04"},{"type":"Formulation","number":"10631746","applicant":"NOVADAQ TECHNOLOGIES ULC","territory":"US","tradeName":"SPY AGENT GREEN KIT","expiryDate":"2035-08-04"},{"type":"Formulation","number":"11712320","applicant":"NOVADAQ TECHNOLOGIES ULC","territory":"US","tradeName":"SPY AGENT GREEN KIT","expiryDate":"2039-07-14"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=INDOCYANINE GREEN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:21:38.349042+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T06:21:38.348972+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T06:21:44.107705+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INDOCYANINE GREEN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:21:44.517181+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:21:37.234118+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1646/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:21:45.229316+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040811","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:21:37.234146+00:00"}},"allNames":"spy agent green kit","offLabel":[],"synonyms":["indocyanine green","4,5-Benzoindotricarbocyanine","indocyanin green","opthagreen","wofaverdin","indocyanine green sodium"],"timeline":[{"date":"1959-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from AKORN to Renew Pharms"},{"date":"1959-02-09","type":"positive","source":"DrugCentral","milestone":"FDA approval (Akorn)"},{"date":"2007-11-21","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"},{"date":"2018-07-02","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Daiichi Sankyo Company, Limited)"},{"date":"2018-11-21","type":"positive","source":"FDA Orange Book","milestone":"Spy Agent Green Kit approved — 25MG/VIAL"}],"aiSummary":"Spy Agent Green Kit is a small molecule intervention used in the assessment of amputation healing, specifically for conditions such as lower extremity amputation, above knee amputation, and below knee amputation. It is administered through the SPY Elite Imaging System, which is used to evaluate wound healing in patients undergoing amputation.","approvals":[{"date":"1959-02-09","orphan":false,"company":"AKORN","regulator":"FDA"},{"date":"2018-07-02","orphan":false,"company":"Daiichi Sankyo Company, Limited","regulator":"PMDA"}],"brandName":"Spy Agent Green Kit","ecosystem":[{"indication":"Evaluation of vascular and tissue blood flow","otherDrugs":[],"globalPrevalence":null},{"indication":"Sentinel lymph node mapping in breast cancer","otherDrugs":[],"globalPrevalence":null},{"indication":"Sentinel lymph node mapping in malignant melanoma","otherDrugs":[],"globalPrevalence":330000}],"mechanism":{"novelty":"Follow-on","moaClass":"Dyes","modality":"Small Molecule","drugClass":"Diagnostic Dye","explanation":"","oneSentence":"","technicalDetail":"Indocyanine Green is a cyanine dye that is rapidly taken up by the liver and excreted into the bile, with a half-life of approximately 0.065 hours. It is primarily bound to albumin in the bloodstream, which affects its distribution and clearance."},"commercial":{"launchDate":"1959","_launchSource":"DrugCentral (FDA 1959-02-09, AKORN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3300","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=INDOCYANINE%20GREEN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INDOCYANINE GREEN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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