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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.

Background

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.

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
Indocyanine Green for Injection
国药准字H20249557
化学药品
注射剂
12/1/2024
Indocyanine Green for Injection
国药准字H20073073
化学药品
注射剂(冻干粉针剂)
6/19/2020
Indocyanine Green for Injection
国药准字H20249047
化学药品
注射剂
10/16/2024
Indocyanine Green for Injection
丹东医创药业有限责任公司;杭州澳亚生物技术股份有限公司
国药准字H20055881
化学药品
注射剂
6/19/2020

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
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