indocyanine green 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
3300 3599-32-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • indocyanine green
  • 4,5-Benzoindotricarbocyanine
  • indocyanin green
  • opthagreen
  • wofaverdin
  • indocyanine green sodium
A tricarbocyanine dye that is used diagnostically in liver function tests and to determine blood volume and cardiac output.
  • Molecular weight: 753.99
  • Formula: C43H49N2O6S2
  • CLOGP: 3.99
  • LIPINSKI: 1
  • HAC: 8
  • HDO: 2
  • TPSA: 114.99
  • ALOGS: -7.31
  • ROTB: 14

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
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

Approvals:

DateAgencyCompanyOrphan
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:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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)

None

Bioactivity Summary:

None

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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