indocyanine green 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 3300 | 3599-32-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A tricarbocyanine dye that is used diagnostically in liver function tests and to determine blood volume and cardiac output.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Hosey CM, Chan R, Benet LZ |
| Vd (Volume of distribution) | 0.04 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 6.80 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.05 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.07 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 1 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 9, 1959 | FDA | AKORN | |
| July 2, 2018 | PMDA | Daiichi Sankyo Company, Limited |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V04CX01 | VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents |
| FDA MoA | N0000175533 | Dyes |
| FDA EPC | N0000175536 | Diagnostic Dye |
| MeSH PA | D004396 | Coloring Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Evaluation of vascular and tissue blood flow | indication | 35202002 | |
| Sentinel lymph node mapping in breast cancer | indication | 274415007 | |
| Sentinel lymph node mapping in malignant melanoma | indication | 274415007 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 0.41 | acidic |
| pKa2 | 1.01 | acidic |
| pKa3 | 4.91 | Basic |
| pKa4 | 4.31 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 9421280 | Nov. 24, 2025 | VISUALIZATION OF EXTRAHEPATIC BILIARY DUCT ATTACHED TO DONOR ORGAN IN PATIENTS 12 YEARS AND OLDER |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 9421280 | Nov. 24, 2025 | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF DONOR ORGAN OR ATTACHED VESSEL IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 8185176 | June 4, 2028 | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF VESSEL WITH ARTERIOVENOUS MALFORMATION IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 8647605 | Feb. 11, 2029 | VISUALIZATION OF EXTRAHEPATIC BILIARY DUCT ATTACHED TO TRANSPLANTED ORGAN IN PATIENTS 12 YEARS AND OLDER |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 8647605 | Feb. 11, 2029 | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF TRANSPLANTED ORGAN OR ATTACHED VESSEL IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 8406860 | April 9, 2029 | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION IN SURGICAL FLAPS IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY |
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | 10631746 | Aug. 4, 2035 | MEASURING TIME-VARYING CHANGE IN BLOOD IN A TISSUE VOLUME USING MODIFIED BEER-LAMBERT LAW IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 25MG/VIAL | SPY AGENT GREEN KIT | NOVADAQ TECH | N211580 | Nov. 21, 2018 | RX | POWDER | INTRAVENOUS, INTERSTITIAL | June 5, 2026 | FOR FLUORESCENCE IMAGING OF LYMPH NODES AND DELINEATION OF LYMPHATIC VESSELS DURINGLYMPHATIC MAPPING IN ADULTS WITH BREAST CANCER FOR WHICH THIS PROCEDURE IS A COMPONENT OF INTRAOPERATIVEMANAGEMENT |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4018103 | VUID |
| N0000146441 | NUI |
| D01342 | KEGG_DRUG |
| 4018103 | VANDF |
| C0021234 | UMLSCUI |
| CHEBI:31696 | CHEBI |
| CHEMBL1646 | ChEMBL_ID |
| CHEMBL1201304 | ChEMBL_ID |
| CHEMBL1615807 | ChEMBL_ID |
| D007208 | MESH_DESCRIPTOR_UI |
| DB16024 | DRUGBANK_ID |
| 4844 | IUPHAR_LIGAND_ID |
| IX6J1063HV | UNII |
| 5282412 | PUBCHEM_CID |
| 5775 | RXNORM |
| 162283 | MMSL |
| 4876 | MMSL |
| d04098 | MMSL |
| 001225 | NDDF |
| 384954007 | SNOMEDCT_US |
| 7292004 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Indocyanine green | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49673-424 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | ANDA | 19 sections |
| Indocyanine green | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66259-424 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | ANDA | 20 sections |
| IC-Green | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66259-701 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | NDA | 21 sections |
| IC-GREEN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69450-701 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | NDA | 21 sections |
| Indocyanine green | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75874-424 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | ANDA | 19 sections |
| IC-Green | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75874-701 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25 mg | INTRAVENOUS | NDA | 21 sections |