LABELS · bb82db71-b087-4274-bd9c-cb388d7dbaeb

IC-Green

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-01-30
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro- vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older. 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older . 1.3 Lymphatic Mapping of Cervical and Uterine Cancer IC-GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management . 1.4 Ophthalmic Angiography IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

Full extracted label fields

application numbers

NDA011525

boxed warning exact

brand names

IC-Green

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ccd92843-1f0a-4ece-9978-4b300d158886

generic names

INDOCYANINE GREEN

bb82db71-b087-4274-bd9c-cb388d7dbaeb

indications and usage exact

1 INDICATIONS AND USAGE • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro- vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older. 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older . 1.3 Lymphatic Mapping of Cervical and Uterine Cancer IC-GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management . 1.4 Ophthalmic Angiography IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

indications and usage tables exact

is original packager

true

manufacturer names

Renew Pharmaceuticals Limited

matched search terms

cancer

package ndcs

70100-825-02
70100-725-01
0409-4887-17
70100-810-02
70100-710-01

product ndcs

70100-810
70100-825

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, For determining Cardiac Output, Hepatic Function, and Liver Blood Flow (1.1) Removed 12/2024 Indications and Usage ( 1.1 , 1.2 , 1.3 ) 12/2024 Dosage and Administration, Indicator-Dilution Studies and Hepatic Function Studies (2.1, 2.2) Removed 12/2024 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.5 ) 12/2024 Dosage and Administration ( 2.5 ) 01/2026

record type

complete_spl_indications_section_candidate

routes

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · unclassified context

application numbers

NDA011525

brand names

IC-Green

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 223
end exclusive: true
exact text: 1 INDICATIONS AND USAGE • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstruc
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 0

current approval status

not_reconciled

duplicate text group

dup-cd1e9e7057ddf9c30aff

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-666514300aa84ede4865

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 23
end exclusive: true
exact text: 1 INDICATIONS AND USAGE
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 2 · unclassified context

application numbers

NDA011525

brand names

IC-Green

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 560
end exclusive: true
exact text: 1 INDICATIONS AND USAGE • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapp
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 0

current approval status

not_reconciled

duplicate text group

dup-3c9a31d9500e264742a6

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-80a76c5d03ae21468125

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

Source null

qualifier mentions

context exact
ncluding general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 )
kind
age
polarity
not_inferred
span
end
306
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
300
context exact
neral minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 )
kind
age
polarity
not_inferred
span
end
329
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
311
context exact
asive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 )
kind
age
polarity
not_inferred
span
end
356
end exclusive
true
exact text
aged 1 month and older ( 1
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
330

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 360
end exclusive: true
exact text: • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 )
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 24

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · unclassified context

application numbers

NDA011525

brand names

IC-Green

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 678
end exclusive: true
exact text: rointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 161

current approval status

not_reconciled

duplicate text group

dup-94f3b1bc263ff14fcc14

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-e5610271f8ba42b7981d

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

Source null

qualifier mentions

context exact
• Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 )
kind
age
polarity
not_inferred
span
end
423
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
417
context exact
escence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 )
kind
age
polarity
not_inferred
span
end
446
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
428
context exact
extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 )
kind
age
polarity
not_inferred
span
end
474
end exclusive
true
exact text
aged 12 years and older ( 1
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
447

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 478
end exclusive: true
exact text: • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 )
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 361

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA011525

brand names

IC-Green

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 814
end exclusive: true
exact text: gical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and m
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 279

current approval status

not_reconciled

duplicate text group

dup-9868136f114fca41326c

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-9476b70821e368d3a10e

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

Source null

qualifier mentions

context exact
mph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 )
kind
age
polarity
not_inferred
span
end
573
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
567

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 614
end exclusive: true
exact text: • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 )
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 479

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · unclassified context

application numbers

NDA011525

brand names

IC-Green

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 880
end exclusive: true
exact text: n adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro- vasculature), blood flow and tissue perfusion before, during
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 415

current approval status

not_reconciled

duplicate text group

dup-939fc73fc43913aba94c

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-2d1d439f4dc5ebcf225e

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

Source null

qualifier mentions

context exact
• Ophthalmic angiography in adults and pediatric patients ( 1.4 )
kind
age
polarity
not_inferred
span
end
649
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
643
context exact
• Ophthalmic angiography in adults and pediatric patients ( 1.4 )
kind
age
polarity
not_inferred
span
end
672
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
654

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 680
end exclusive: true
exact text: • Ophthalmic angiography in adults and pediatric patients ( 1.4 )
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 615

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · positive indication candidate

application numbers

NDA011525

brand names

IC-Green

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1296
end exclusive: true
exact text: Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) • Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro- vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older. 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older . 1.3 Lymphatic M
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 481

current approval status

not_reconciled

duplicate text group

dup-0afdb0a6536ec04102ec

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-510e52fb329b4196fe55

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

end: 764
end exclusive: true
exact text: is indicated
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 752

qualifier mentions

context exact
including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older.
kind
age
polarity
not_inferred
span
end
1049
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1043
context exact
eneral minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older.
kind
age
polarity
not_inferred
span
end
1072
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1054
context exact
vasive surgical procedures in adults and pediatric patients aged 1 month and older.
kind
age
polarity
not_inferred
span
end
1095
end exclusive
true
exact text
aged 1 month and older
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1073

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1096
end exclusive: true
exact text: 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro- vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older.
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 681

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 7 · positive indication candidate

application numbers

NDA011525

brand names

IC-Green

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1480
end exclusive: true
exact text: ar, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older. 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older . 1.3 Lymphatic Mapping of Cervical and Uterine Cancer IC-GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervica
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 897

current approval status

not_reconciled

duplicate text group

dup-deae1f17222a17638826

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-2df4cec771e336592f75

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

end: 1166
end exclusive: true
exact text: is indicated
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1154

qualifier mentions

context exact
d for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older .
kind
age
polarity
not_inferred
span
end
1231
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1225
context exact
escence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older .
kind
age
polarity
not_inferred
span
end
1254
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1236
context exact
extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older .
kind
age
polarity
not_inferred
span
end
1278
end exclusive
true
exact text
aged 12 years and older
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1255

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1280
end exclusive: true
exact text: 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older .
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1097

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 8 · positive indication candidate

application numbers

NDA011525

brand names

IC-Green

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1688
end exclusive: true
exact text: onth and older. 1.2 Visualization of Extrahepatic Biliary Ducts IC-GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older . 1.3 Lymphatic Mapping of Cervical and Uterine Cancer IC-GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management . 1.4 Ophthalmic Angiography IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1081

current approval status

not_reconciled

duplicate text group

dup-e32d902b38e9c4126f24

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-e8f6f4f3add76b8ad746

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

end: 1355
end exclusive: true
exact text: is indicated
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1343

qualifier mentions

context exact
elineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure i
kind
age
polarity
not_inferred
span
end
1467
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1461

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1571
end exclusive: true
exact text: 1.3 Lymphatic Mapping of Cervical and Uterine Cancer IC-GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management .
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1281

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 9 · positive indication candidate

application numbers

NDA011525

brand names

IC-Green

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1688
end exclusive: true
exact text: imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management . 1.4 Ophthalmic Angiography IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1372

current approval status

not_reconciled

duplicate text group

dup-4f77d17529b6057071cb

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-a00a14ada538acc0ce7b

label id

bb82db71-b087-4274-bd9c-cb388d7dbaeb

positive predicate support span

end: 1620
end exclusive: true
exact text: is indicated
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1608

qualifier mentions

context exact
IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
kind
age
polarity
not_inferred
span
end
1664
end exclusive
true
exact text
adults
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1658
context exact
s indicated for use in ophthalmic angiography in adults and pediatric patients.
kind
age
polarity
not_inferred
span
end
1687
end exclusive
true
exact text
pediatric patients
label id
bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start
1669

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1688
end exclusive: true
exact text: 1.4 Ophthalmic Angiography IC-GREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
label id: bb82db71-b087-4274-bd9c-cb388d7dbaeb
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b87f73627c1de95da9ef980034d34d2ff5ad4134d706f2135909d88a39d1577e
start: 1572

source url

https://api.fda.gov/drug/label.json?search=id%3A%22bb82db71-b087-4274-bd9c-cb388d7dbaeb%22

spl effective date

2026-01-30

spl set id

ccd92843-1f0a-4ece-9978-4b300d158886

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice