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Zyogreen Indocyanine Green 2.5 mg/mL Injection, Solution — NDC 25021-0841-10 package photo

Zyogreen Indocyanine Green 2.5 mg/mL Injection, Solution

by Sagent Pharmaceuticals · 5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE
NDC 25021-0841-10
🏷️ FDA NDC (as labeled) 25021-841-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 25021-841-10
Product NDC 25021-841
11-digit billing NDC 25021084110
UNII IX6J1063HV
Application # NDA218579
SPL Set ID b2de0c9a-0065-4f2c-9983-add39525f3a3
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-16
Route INTERSTITIAL, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance INDOCYANINE GREEN
Why two NDCs? The FDA registers this code as 25021-841-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 25021-0841-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSagent Pharmaceuticals
Application holderPROVEPHARM SAS
FDA applicationNDA218579 (NDA)
Labeler code25021
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio209 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII F5WR8N145C
    Sodium iodide is an inorganic salt containing iodine. In medications, it acts as a source of iodine and may serve as a preservative or stabilizer to help maintain product quality and shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zyogreen 2.5 mg/mLthis 25021-0841-10 Sagent 5 ampules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zyogreen (this brand).

Top reported reactions

Palpitations10
Urticaria9
Dyspnoea8
Haemangioma Congenital8
Low Birth Weight Baby8
Patent Ductus Arteriosus8
Liver Function Test Increased7

Age at onset

Neonate3
Adult5
Elderly1

Reporter sex

103 reports
Male · 33%
Female · 65%
Unknown · 2%

Serious outcomes

Disabling5
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
25021-0841-10 You're viewing this 5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE 2026-07-16 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 25021-841-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 25021-0841-10, written without dashes as 25021084110. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 25021-0841-10, the first segment (25021) is the labeler code FDA assigned to Sagent Pharmaceuticals; the middle segment (0841) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sagent Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sagent Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

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 )

1.1Visualization 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.

1.2Visualization 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.

1.3Lymphatic 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.

1.4Ophthalmic Angiography ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Visualization of vessels, blood flow and tissue perfusion Pediatric patients less than 1 month of age: 0.15 mg/kg Adults and pediatric patients 1 month of age and older: 1.25 mg to 5 mg by intravenous injection ( 2.2 ) Extremity perfusion visualization through the skin Pediatric patients less than 1 month of age: 0.15 mg/kg Pediatric patients 1 month of age and older: 1.25 mg to 5 mg Adults: 3.75 mg to 10 mg by intravenous injection ( 2.2 ) Visualization of extrahepatic biliary ducts Pediatric patients from birth to less than 1 year of age: 0.1 mg/kg (not to exceed 2.5 mg) 12 to 24 hours prior to surgery Adults and pediatric patients 6 years of age and older: 2.5 mg by intravenous injection at least 45 minutes prior to surgery ( 2.3 ) Lymphatic mapping of cervical and uterine cancer in adults 5 mg interstitially as four 1.25 mg injections.

See Full Prescribing Information for injection techniques. ( 2.4 ) Ophthalmic Angiography in adults and pediatric patients: doses up to 40 mg by intravenous injection. ( 2.5 ) The total dose must not exceed 2 mg/kg for all patients.

2.1Important Administration Instructions ZYOGREEN is a ready-to-use solution, provided in ampules at a concentration of 2.5 mg per mL. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micrometer or smaller straw/filter needle to ensure that the withdrawn solution contains no particulates.

Visually inspect the withdrawn solution for particulate matter and discoloration prior to administration. Each ampule of ZYOGREEN is for a single dose. Discard any unused portion.

2.2Recommended Dose, Administration and Imaging for Visualization of Vessels, Blood Flow and Tissue Perfusion Dosing Administer the recommended initial dose of ZYOGREEN as a single intravenous injection. The recommended initial dose is based on patient age as shown in Table 1 . Additional doses may be administered to obtain imaging sequences during the procedure.

The maximum total dose for any patient, including all initial and additional doses combined, must not exceed 2 mg/kg. Table 1. Recommended Dose of ZYOGREEN for Visualization of Vessels, Blood Flow and Tissue Perfusion by Age * Dose based on actual body weight Imaging Patient Age Recommended Dose Visualization of vessels, blood flow and tissue perfusion (single imaging sequence) Pediatric patients from birth to less than 1 month of age 0.15 mg/kg * Pediatric patients 1 month of age and older 1.25 mg to 5 mg Adults Extremity perfusion visualization through the skin (single imaging sequence) Pediatric patients from birth to less than 1 month of age 0.15 mg/kg * Pediatric patients 1 month of age and older 1.25 mg to 5 mg Adults 3.75 mg to 10 mg Administration Prior to the imaging procedure, draw the desired dose of ZYOGREEN into a syringe.

For adults, prepare 10 mL of 0.9% Sodium Chloride Injection in a separate syringe for flushing. For pediatric patients, adjust the amount and type of flush for the individual patient to avoid volume and sodium overload. Administer via a central or peripheral venous line using a three-way stopcock.

Inject ZYOGREEN as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush. Imaging Instructions Use ZYOGREEN with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of vessels, blood flow and tissue perfusion.

A fluorescence response should be visible in blood vessels within 5 seconds to 15 seconds after injection.

2.3Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts Dosing and Administration Administer the recommended dose of ZYOGREEN as a single intravenous injection. The initial dose and timing of administration are based on patient age as shown in Table 2 . Additional doses may be administered to obtain imaging sequences during the procedure. The maximum total dose for any patient, including all initial and additi…

💊 Dosage Forms and Strengths 52 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 25 mg per 10 mL (2.5 mg per mL) of indocyanine green as a deep emerald-green ready-to-use solution in a single-dose ampule. Injection: 25 mg per 10 mL (2.5 mg per mL) of indocyanine green as a ready-to-use solution in a single-dose ampule ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to indocyanine green ( 4 )

⚠️ Warnings and Cautions 124 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients. ( 5.1 )

5.1Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green, the active ingredient in ZYOGREEN [see Adverse Reactions ( 6 )]. ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green [see Contraindications ( 4 )] . Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.

5.2Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration [see Drug Interactions ( 7 )].

🤒 Adverse Reactions 109 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions have been identified during post-approval use of indocyanine green, the active ingredient in ZYOGREEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders : Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 74 words ▾

7 DRUG INTERACTIONS Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of ZYOGREEN. ( 7 ) Interference with Thyroid Radioactive Iodine Uptake Studies Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of ZYOGREEN.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ZYOGREEN in pregnant women. Available data from a very small number of scientific literature studies with indocyanine green use in pregnant women over several decades have not reported any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Data from one small study in which indocyanine green was administered intravenously to pregnant women during labor suggest there is no placental transfer of the drug.

Animal reproduction studies have not been conducted with indocyanine green. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary Seventeen cases of indocyanine green use in lactating women have been reported in the scientific literature with no adverse events observed in the breastfed infant. However, there are no data on the presence of indocyanine green in human milk or the effects on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZYOGREEN and any potential adverse effects on the breastfed infant from ZYOGREEN or from the underlying maternal condition.

8.4Pediatric Use Use in Pediatric Patients for Visualization of Vessels, Blood Flow and Tissue Perfusion The safety and effectiveness of ZYOGREEN 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 have been established in pediatric patients. Use of ZYOGREEN for this indication in pediatric patients is supported by evidence from clinical trials in adults and published studies that demonstrated the utility of indocyanine green for blood vessel evaluation and assessment of tissue perfusion in 59 pediatric patients, including 6 neonates, during surgeries within the indicated surgical categories.

Use in Pediatric Patients for Visualization of Extrahepatic Biliary Ducts The safety and effectiveness of ZYOGREEN for fluorescence imaging of extrahepatic biliary ducts have been established in pediatric patients from birth to less than 1 year of age and in those 6 years of age and older. Use of ZYOGREEN for this indication in these age groups is supported by evidence from clinical trials in adults and from the following published studies in pediatric patients. For patients less than 1 year of age, supporting publications included two prospective observational studies and one retrospective case series evaluating a total of 34 pediatric patients (age range: 2 to 119 days) with jaundice undergoing Kasai portoenterostomy who received indocyanine green for fluorescence imaging of biliary structures.

For patients 6 years of age and older, a supporting publication consisted of a prospective, single institution case series in 31 pediatric patients (age range: 6 to 18 years) undergoing cholangiography with indocyanine green during laparoscopic cholecystectomy. The safety and effectiveness of ZYOGREEN have not been established for fluorescence imaging of extrahepatic biliary ducts in pediatric patients 1 year to less than 6 years of age. Use in Pediatric Patients for Ophthalmic Angiography ZYOGREEN is indicated for ophthalmic angiography in pediatric patients.

Use in Pediatric Patients for Lymphatic Mapping of Cervical and Uterine Cancer The safety and effectiveness of ZYOGREEN for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients.

8.5 Geriatric Use Of the total number of subjec…

🤰 Pregnancy 133 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ZYOGREEN in pregnant women. Available data from a very small number of scientific literature studies with indocyanine green use in pregnant women over several decades have not reported any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Data from one small study in which indocyanine green was administered intravenously to pregnant women during labor suggest there is no placental transfer of the drug.

Animal reproduction studies have not been conducted with indocyanine green. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Use in Pediatric Patients for Visualization of Vessels, Blood Flow and Tissue Perfusion The safety and effectiveness of ZYOGREEN 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 have been established in pediatric patients. Use of ZYOGREEN for this indication in pediatric patients is supported by evidence from clinical trials in adults and published studies that demonstrated the utility of indocyanine green for blood vessel evaluation and assessment of tissue perfusion in 59 pediatric patients, including 6 neonates, during surgeries within the indicated surgical categories.

Use in Pediatric Patients for Visualization of Extrahepatic Biliary Ducts The safety and effectiveness of ZYOGREEN for fluorescence imaging of extrahepatic biliary ducts have been established in pediatric patients from birth to less than 1 year of age and in those 6 years of age and older. Use of ZYOGREEN for this indication in these age groups is supported by evidence from clinical trials in adults and from the following published studies in pediatric patients. For patients less than 1 year of age, supporting publications included two prospective observational studies and one retrospective case series evaluating a total of 34 pediatric patients (age range: 2 to 119 days) with jaundice undergoing Kasai portoenterostomy who received indocyanine green for fluorescence imaging of biliary structures.

For patients 6 years of age and older, a supporting publication consisted of a prospective, single institution case series in 31 pediatric patients (age range: 6 to 18 years) undergoing cholangiography with indocyanine green during laparoscopic cholecystectomy. The safety and effectiveness of ZYOGREEN have not been established for fluorescence imaging of extrahepatic biliary ducts in pediatric patients 1 year to less than 6 years of age. Use in Pediatric Patients for Ophthalmic Angiography ZYOGREEN is indicated for ophthalmic angiography in pediatric patients.

Use in Pediatric Patients for Lymphatic Mapping of Cervical and Uterine Cancer The safety and effectiveness of ZYOGREEN for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients.

🧓 Geriatric Use 176 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of indocyanine green for visualization of vessels, blood flow and tissue perfusion, 7% were 65 and over, while 1% were 75 and over. Of the total number of subjects in clinical studies of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping of cervical and uterine cancer, 9% were 65 and over, while 2% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients.

Clinical studies of indocyanine green for visualization of extrahepatic biliary ducts did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near infrared light for indocyanine green to absorb, resulting in excitation of the indocyanine green, and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor.

These optical properties of indocyanine green are utilized in fluorescence imaging of the micro- and macro- vasculature, blood flow and tissue perfusion, the extrahepatic biliary ducts, and for lymphatic mapping of lymph nodes and lymphatic vessels.

12.2Pharmacodynamics There is no pharmacodynamic data.

12.3Pharmacokinetics Distribution Following intravenous injection, indocyanine green binds to plasma proteins (98%) and is largely confined to the intravascular compartment. Indocyanine green undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebrospinal uptake of the dye. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin.

Following interstitial injection, indocyanine green binds to proteins in lymph fluid and the interstitial space, is taken up by the lymphatic vessels, and drains to the lymph nodes. Since excessive dye extravasation does not take place in the highly fenestrated choroidal vasculature, ZYOGREEN is useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera. Elimination Indocyanine green is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile.

🧬 Mechanism of Action 119 words ▾

12.1Mechanism of Action When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near infrared light for indocyanine green to absorb, resulting in excitation of the indocyanine green, and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor.

These optical properties of indocyanine green are utilized in fluorescence imaging of the micro- and macro- vasculature, blood flow and tissue perfusion, the extrahepatic biliary ducts, and for lymphatic mapping of lymph nodes and lymphatic vessels.

📦 How Supplied / Storage and Handling 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZYOGREEN (Indocyanine Green Injection), is a deep emerald-green ready-to-use solution in amber glass ampules supplied as follows: NDC ZYOGREEN ® (Indocyanine Green Injection) (2.5 mg per mL) Package Factor 25021-841-10 25 mg per 10 mL Single-Dose Ampules 5 ampules per carton Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store in original carton to protect from light.

Do not refrigerate or freeze. Use immediately after opening ampule. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. Not made with natural rubber latex.

📋 Description 119 words ▾

11 DESCRIPTION ZYOGREEN (indocyanine green injection) is an optical imaging agent for intravenous or interstitial use. The chemical name for indocyanine green is 1 H- Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2 H -benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. It has a molecular formula of C 43 H 47 N 2 NaO 6 S 2 and a molecular mass of 774.96 g/mol.

The structural formula is shown below. Indocyanine green has a peak spectral absorption at 805 nm in blood. ZYOGREEN is a sterile, ready-to-use solution.

Each mL contains 2.5 mg of indocyanine green with not more than 0.125 mg sodium iodide and the following inactive ingredients: 1 mg sodium ascorbate and water for injection with a pH between 5.5 and 7.5. structural formula

💬 Information for Patients 79 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise patients to seek medical attention for reactions following injection of ZYOGREEN such as difficulty breathing, swollen tongue or throat, skin reactions including hives, itching and flushed or pale skin, low blood pressure, a weak and rapid pulse and other symptoms or signs of an anaphylactic reaction [see Warnings and Precautions ( 5.1 )] . sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in France ©2026 Sagent Pharmaceuticals June 2026

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 25021-0840-05 · Sagent 25047-0751-01 · DMG →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.