LABELS · 1aa18dd8-8838-4698-b358-6956f8b94929

Zyogreen

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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: 2026-07-16
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ZYOGREEN is an optical imaging agent 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 ( 1.1 ) Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age 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 ZYOGREEN 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. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN 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 ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

Full extracted label fields

application numbers

NDA218579

boxed warning exact

brand names

Zyogreen

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2de0c9a-0065-4f2c-9983-add39525f3a3

generic names

INDOCYANINE GREEN

1aa18dd8-8838-4698-b358-6956f8b94929

indications and usage exact

1 INDICATIONS AND USAGE ZYOGREEN is an optical imaging agent 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 ( 1.1 ) Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age 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 ZYOGREEN 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. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN 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 ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

indications and usage tables exact

is original packager

true

manufacturer names

Sagent Pharmaceuticals

matched search terms

cancer

package ndcs

25021-841-10

product ndcs

25021-841

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTERSTITIAL
INTRAVENOUS

rxcuis

source batch

file

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Source passages and status connections

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

Passage 1 · positive indication candidate

application numbers

NDA218579

brand names

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exact text: 1 INDICATIONS AND USAGE ZYOGREEN is an optical imaging agent 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 ( 1.1 ) Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age 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 )
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prior therapy: Source null
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use intent

diagnostic_candidate

Passage 2 · positive indication candidate

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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 ZYOGREEN 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. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and
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exact text: 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion ZYOGREEN 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.
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Passage 3 · positive indication candidate

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exact text: during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervica
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exact text: 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older.
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exact text: hepatic Biliary Ducts ZYOGREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN 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 ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
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exact text: 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN 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.
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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 5 · positive indication candidate

application numbers

NDA218579

brand names

Zyogreen

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

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exact text: e 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 ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
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start: 1453

current approval status

not_reconciled

duplicate text group

dup-2b9adbaae195de7d4145

extraction review status

automated_candidate_pending_source_review

generic names

INDOCYANINE GREEN

ind-span-788e9ee414f8c399c795

label id

1aa18dd8-8838-4698-b358-6956f8b94929

positive predicate support span

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qualifier mentions

context exact
ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
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age
polarity
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1745
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true
exact text
adults
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source array index
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source text sha256
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1739
context exact
s indicated for use in ophthalmic angiography in adults and pediatric patients.
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exact text
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source text sha256
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start
1750

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

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exact text: 1.4 Ophthalmic Angiography ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.
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start: 1653

source url

https://api.fda.gov/drug/label.json?search=id%3A%221aa18dd8-8838-4698-b358-6956f8b94929%22

spl effective date

2026-07-16

spl set id

b2de0c9a-0065-4f2c-9983-add39525f3a3

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