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Indocyanine green acid form

Generic Name
Indocyanine green acid form
Brand Names
Ic-green
Drug Type
Small Molecule
Chemical Formula
C43H48N2O6S2
CAS Number
28782-33-4
Unique Ingredient Identifier
C4V974V932

Overview

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)-2H-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 with no more than 5% sodium iodide.

Indication

For Determining Cardiac Output, Hepatic Function and Liver Blood Flow For ophthalmic angiography

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 2, 2025

Comprehensive Monograph on Indocyanine Green (DB09374)

Executive Summary

Indocyanine Green (ICG) is a tricarbocyanine dye with a remarkable history, evolving from a mid-20th-century diagnostic tool into a cornerstone of modern near-infrared (NIR) fluorescence-guided surgery. First approved by the U.S. Food and Drug Administration (FDA) in 1959, its initial applications were centered on measuring cardiac output and hepatic function, leveraging its unique pharmacokinetic profile. This profile is characterized by rapid and strong binding to plasma proteins, which confines the molecule to the intravascular space, and an exclusive, rapid elimination pathway through the liver into the bile without undergoing metabolic alteration.

The advent of sophisticated NIR imaging technologies has catalyzed a renaissance for ICG, transforming it into a versatile intraoperative navigation aid. Its spectral properties, with absorption and emission peaks in the NIR window, allow for deep tissue penetration with a high signal-to-noise ratio, enabling real-time visualization of anatomical structures and physiological processes. Key contemporary applications include ophthalmic angiography for diagnosing choroidal diseases, intraoperative cholangiography to prevent bile duct injury during cholecystectomy, comprehensive perfusion assessment to reduce anastomotic leaks in colorectal surgery and flap necrosis in reconstructive surgery, and high-precision sentinel lymph node mapping in oncologic surgery.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/29
Phase 1
Recruiting
Eva Sevick
2025/04/23
Phase 1
Recruiting
OPTOSURGICAL, LLC
2025/03/12
Phase 4
Not yet recruiting
2025/03/10
Phase 1
Not yet recruiting
VPIX Medical
2024/11/04
Not Applicable
Not yet recruiting
City of Hope Medical Center
2024/10/07
Phase 4
Completed
2024/06/06
Early Phase 1
Recruiting
2024/05/03
Phase 4
Recruiting
2024/10/11
Phase 2
Not yet recruiting
2024/03/25
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Novadaq Technologies, Inc.
69450-701
INTRAVENOUS
25 mg in 1 1
3/2/2015
Novadaq Technologies Inc.
75874-424
INTRAVENOUS
25 mg in 1 1
11/18/2011
Novadaq Technologies Inc.
49673-424
INTRAVENOUS
25 mg in 1 1
5/22/2012
Novadaq Technologies Inc.
66259-424
INTRAVENOUS
25 mg in 1 1
11/11/2015
Novadaq Technologies Inc.
66259-701
INTRAVENOUS
25 mg in 1 1
9/17/2013
Novadaq Technologies Inc.
75874-701
INTRAVENOUS
25 mg in 1 1
8/30/2013

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
DIAGNOGREEN FOR INJ 25MG/VIAL
N/A
N/A
N/A
11/10/1988

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SPY AGENT GREEN Indocyanine green
369670
Medicine
A
2/28/2024
VERDYE indocyanine green 25 mg powder for injection vial
391356
Medicine
A
3/15/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
INDOCYANINE GREEN FOR INJECTION, USP
diagnostic green limited
02485796
Powder For Solution - Intravenous
25 MG / VIAL
6/11/2019
SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT
Novadaq Technologies ULC
02483696
Kit ,  Powder For Solution - Interstitial
25 MG / VIAL
6/4/2019
INDOCYANINE GREEN FOR INJECTION KIT
diagnostic green limited
02485818
Powder For Solution ,  Kit - Intravenous
25 MG / VIAL
N/A
IC-GREEN
02014793
Powder - Intravenous
25 MG / VIAL
12/31/1994
SPY AGENT GREEN KIT FOR SPY ELITE
Novadaq Technologies ULC
02483661
Powder For Solution ,  Kit - Intravenous
25 MG / VIAL
6/4/2019
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT
Novadaq Technologies ULC
02527839
Powder For Solution ,  Kit - Intravenous
25 MG / VIAL
2/15/2023
SPY AGENT GREEN
Novadaq Technologies ULC
02483653
Powder For Solution - Intradermal ,  Interstitial ,  Intravenous
25 MG / VIAL
6/4/2019
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT
Novadaq Technologies ULC
02483688
Kit ,  Powder For Solution - Intravenous
25 MG / VIAL
6/4/2019
SPY AGENT GREEN KIT FOR SPY-PHI
Novadaq Technologies ULC
02498677
Kit ,  Powder For Solution - Intradermal ,  Interstitial ,  Intravenous
25 MG / VIAL
12/3/2020
INDOCYANINE GREEN FOR INJECTION KIT
diagnostic green limited
02485826
Powder For Solution ,  Kit - Intravenous
25 MG / VIAL
6/11/2019

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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