Home › NDC Lookup › Ingredients › Indocyanine Green And Water › 70100-0424-02
Indocyanine Green Kit — NDC 70100-0424-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Indocyanine Green Kit — NDC 70100-424-02 (Billing 70100-0424-02)

by Renew Pharmaceuticals Limited · 6 PACKAGE in 1 CARTON / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC

This is a package of Indocyanine Green Kit from Renew Pharmaceuticals Limited, marketed since Jan 2008 and currently FDA-listed. It is this product's only package size.

NDC 70100-0424-02
🏷️ FDA NDC (as labeled) 70100-424-02 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 70100-424-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70100 labeler · 424 product · 02 package
Package marketed since
Jan 1, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7010042402 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70100-424-02
Product NDC 70100-424
11-digit billing NDC 70100042402
NCPDP billing unit EA — each (per item)
Application # ANDA040811
SPL Set ID a6f24787-c243-445a-9c55-7c7479b292d9
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-01-01
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94200055002115
GPI class Indocyanine Green
GCN Seq No 003110
GCN 09871
HICL code 001380
Ingredient (HICL) Indocyanine Green
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7U
Therapeutic class — specific (HIC3) Biliary Diagnostics,Radiopaque
AHFS code 36:18.00.00
AHFS class Cardiac Function
FDB label name INDOCYANINE GREEN 25 MG VIAL
FDB brand name Indocyanine Green
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003110
  • GCN: 09871
  • GPI-14 (Medi-Span): 94200055002115
  • HICL (First Databank): 001380
  • AHFS class code: 36:18.00.00
Why two NDCs? The FDA registers this code as 70100-424-02 — 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 → 70100-0424-02. 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.

Clinical

Label name INDOCYANINE GREEN 25 MG VIAL Ingredient Indocyanine Green

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.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70100-0424-02 You're viewing this Main listing 6 PACKAGE in 1 CARTON / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC 2008-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Indocyanine Green 73624-0424-02 Olympus 1 kit — AP FDA listed —
Indocyanine Greenthis 70100-0424-02 Renew 1 kit — AP FDA listed —
Indocyanine Green and Water 68225-0069-02 Patheon 1 kit — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerRenew Pharmaceuticals Limited
Application holderRENEW PHARMACEUTICALS LTD
FDA applicationANDA040811 (ANDA)
Labeler code70100
First marketedJan 2008
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Renew Pharmaceuticals Limited labeler code 70100

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Indocyanine Green for injection is indicated: Indocyanine Green for injection 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 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 )

1.1Visualization of Vessels, Blood Flow and Tissue Perfusion Indocyanine 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.

1.2Visualization of Extrahepatic Biliary Ducts Indocyanine Green is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older .

1.3Lymphatic Mapping of Cervical and Uterine Cancer Indocyanine 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.

1.4Ophthalmic Angiography Indocyanine Green 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 (2.5 mg/mL solution) o 1.25 mg to 5 mg by intravenous injection is recommended for a surgical procedure in adults and pediatric patients aged 1 month and older. o 3.75 mg to 10 mg by intravenous injection is recommended for visualization of perfusion in extremities through the skin for plastic, micro- and reconstructive surgeries in adults. o Additional doses may be administered. Do not exceed a total dose of 2 mg/kg. ( 2.1 ) • Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older (2.5 mg/mL solution) o 2.5 mg by intravenous injection at least 45 minutes prior to surgery. o Additional doses may be administered.

Do not exceed a total dose of 2 mg/kg. ( 2.2 ) • Lymphatic mapping of cervical and uterine cancer in adults (1.25 mg/mL solution) o 5 mg interstitially as four 1 mL injections. o See Full Prescribing Information for injection techniques. ( 2.3 ) • Ophthalmic Angiography o Doses up to 40 mg in 2 ml of Sterile Water for Injection by intravenous injection.

( 2.4 ) • See Full Prescribing Information for reconstitution instructions. ( 2.5 ).

2.1Indicator-Dilution Studies Dosing Adults: The recommended dose of Indocyanine Green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in adults is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. For visualization of perfusion in extremities through the skin in adults, the recommended dose is 3.75 mg to 10 mg administered intravenously as 1.5 mL to 4 mL of a 2.5 mg/mL solution. Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride Injection.

Pediatric patients aged 1 month and older: The recommended dose of Indocyanine Green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in pediatric patients aged 1 month and older is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. Lower doses may be administered in younger patients and in those with lower body weight. Adjust the amount and type of flush to avoid volume and/or sodium overload.

In both adults and pediatric patients aged 1 month and older, additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg. Administration Prior to the imaging procedure, draw up the desired dose of Indocyanine Green solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride Injection.

Administer via a central or peripheral venous line using a three-way stopcock attached to an injection port on the infusion line. Inject the prepared Indocyanine Green into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush.

Imaging Instructions Indocyanine Green may be used 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.

2.2Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts Dosing and Administration The recommended dose of Indocyanine Green for visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older is 2.5 mg administered intravenously as 1 mL of a 2.5 mg/mL solution at least 45 minutes prior to surgery. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed a total dose of 2 mg/kg.

Imaging Instructions Indocyanine Green may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. Fluorescence is visible in the biliary tree within 45 minutes after injection.

2.3Recommended Dose, Administration… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 25 mg of indocyanine green as a sterile, lyophilized, green powder for reconstitution provided in a 25 mL single-patient-use vial. For injection: 25 mg of indocyanine green as a lyophilized, green powder for reconstitution in a single-patient-use vial ( 3 )

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS Indocyanine Green 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 129 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Hypersensitivity reactions including anaphylaxis and urticaria have occurred. 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 [see Adverse Reactions ( 6 )]. Indocyanine Green 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 Indocyanine Green 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 105 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. 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 Diagnostic Green LLC at 1-844-424-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 77 words ▾

7 DRUG INTERACTIONS Interference with Thyroid Radioactive Iodine Uptake Studies Because Indocyanine Green 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 Indocyanine Green. Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of Indocyanine Green.

( 7 )

👥 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 Indocyanine Green 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 Indocyanine Green and any potential adverse effects on the breastfed infant from Indocyanine Green or from the underlying maternal condition.

8.4Pediatric Use Use of Indocyanine Green for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients aged 1 month and older. Pediatric use is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular, and plastic, micro- and reconstructive surgical procedures, and by clinical trials in adults . No overall differences in safety or effectiveness have been observed between pediatric patients and adults.

The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.1 )]. The use of Indocyanine Green for visualization of vessels, blood flow and tissue perfusion has not been established in pediatric patients aged less than 1 month. Use of Indocyanine Green for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 years and older.

Pediatric use is supported by clinical trials in adults in addition to clinical use in pediatric patients. No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.2 )] .

The use of Indocyanine Green for visualization of extrahepatic biliary ducts has not been established in pediatric patients aged less than 12 years. Use of Indocyanine Green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients. Use of Indocyanine Green for ophthalmic angiography has been established in pediatric patients.

Pediatric use is supported by evidence from the published literature.

8.5Geriatric Use Of the total number of patients 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 patients 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. Clinical studies of indocyanine green for visualization of extrahepatic biliary ducts did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

No overall differences in safety or effectiveness were observed b… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 134 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of Indocyanine Green 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 ~1 min read ▾

8.4Pediatric Use Use of Indocyanine Green for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients aged 1 month and older. Pediatric use is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular, and plastic, micro- and reconstructive surgical procedures, and by clinical trials in adults . No overall differences in safety or effectiveness have been observed between pediatric patients and adults.

The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.1 )]. The use of Indocyanine Green for visualization of vessels, blood flow and tissue perfusion has not been established in pediatric patients aged less than 1 month. Use of Indocyanine Green for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 years and older.

Pediatric use is supported by clinical trials in adults in addition to clinical use in pediatric patients. No overall differences in safety or effectiveness have been observed between pediatric patients and adults. The dose range was similar to the effective dose range in adults [see Dosage and Administration ( 2.2 )] .

The use of Indocyanine Green for visualization of extrahepatic biliary ducts has not been established in pediatric patients aged less than 12 years. Use of Indocyanine Green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients. Use of Indocyanine Green for ophthalmic angiography has been established in pediatric patients.

Pediatric use is supported by evidence from the published literature.

🧓 Geriatric Use 176 words ▾

8.5Geriatric Use Of the total number of patients 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 patients 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. Clinical studies of indocyanine green for visualization of extrahepatic biliary ducts did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients. 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 are 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 cerebro-spinal 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, Indocyanine Green 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 118 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 74 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Indocyanine Green for injection is supplied as a kit (NDC 70100-424-02) containing the following: • Six 25 mL single-patient-use vials of Indocyanine Green (25 mg each) as a sterile, lyophilized green powder for reconstitution NDC 70100-424-01 • Six single-dose vials of Sterile Water for Injection (10 mL each) NDC 63323-185-10 or NDC 0409-4887-17 or NDC 0641-6147-01. Storage and Handling Store at 20°C to 25°C (68°F to 77°F).

📋 Description 97 words ▾

11 DESCRIPTION Indocyanine Green for injection is an optical imaging agent for intravenous or interstitial use. Each vial contains 25 mg of indocyanine green with not more than 5% sodium iodide as a sterile, lyophilized, green powder. Indocyanine Green has a pH of 5.5-7.5 when reconstituted with Sterile Water for Injection, USP.

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. Molecular Formula: C43H47N2NaO6S2; Molecular Mass: 774.96 g/mol, with the following structural formula: Indocyanine green has a peak spectral absorption at 805 nm in blood. Structural Formula

💬 Information for Patients 62 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise patients to seek medical attention for reactions following injection of Indocyanine Green 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 )] .

🧬 Pharmacokinetics 171 words ▾

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 cerebro-spinal 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, Indocyanine Green 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.

🧬 Pharmacodynamics 7 words ▾

12.2Pharmacodynamics There are no pharmacodynamic data.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Lymphatic Mapping of Cervical and Uterine Cancer The effectiveness of Indocyanine Green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer has been established based on a study of another formulation of indocyanine green for injection. Below is a description of the FILM Study (NCT 02209532). The study was a randomized, prospective, multi-center, open-label study in patients with early stage uterine or cervical cancer and no known regional nodal or metastatic disease by standard clinical evaluation.

Indocyanine green and a blue dye comparator were injected into the cervix of patients at the beginning of the operative procedure. A total of 176 patients were randomized to receive either indocyanine green followed by blue dye or blue dye followed by indocyanine green. A total of four 1 mL injections of a 1.25 mg/ml solution of indocyanine green for a total dose of 5 mg were administered interstitially into the cervix at the 3 o'clock and 9 o'clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 3 cm) injection at each position.

Lymphatic mapping was performed intraoperatively using a fluorescence imaging device and standard light, followed by excision of tissues identified by indocyanine green, blue dye, or the surgeon's visual and palpation examination. The resected tissues were evaluated by histopathology to confirm presence of lymph nodes. The efficacy of indocyanine green in the detection of lymphatic vessels and lymph nodes during lymphatic mapping procedures was determined by the number of histology-confirmed lymph nodes detected by indocyanine green and/or the blue dye comparator.

The mean age of the 176 patients was 63 years (range: 31 to 88 years); distribution by race and ethnicity was 79% White, 4% Black or African American, 3% Asian, 13% Hispanic/Latino and 1% other. Table 1 shows the distribution of resected, confirmed lymph nodes detected by indocyanine green or blue dye in the modified intent-to-treat population (mlTT). Among the confirmed lymph nodes identified, 93% were identified using indocyanine green, and 43% were identified using blue dye, a difference of 50% [95% confidence interval 39% to 60%].

Table 1: Distribution of Resected, Confirmed Lymph Nodes Detected by Indocyanine Green or Blue Dye (BD) Analysis Population Nodes (n) All Lymph Nodes Detected with Indocyanine Green All Lymph Nodes Detected with BD Lymph Nodes Detected with Indocyanine Green Only Lymph Nodes Detected with BD Only Lymph Nodes Detected with Neither mlTT 513 (476/513) (220/513) (262/513) (6/513) (31/513) 93% 43% 51% 1% 6% Table 2 shows the number of patients with at least one resected, confirmed lymph node and the number of patients with at least one bilateral lymph node pair detected by indocyanine green or blue dye.

With indocyanine green, approximately 97% of patients had at least one resected, confirmed lymph node detected and 73% had at least one bilateral lymph node pair detected, compared with 68% and 28%, respectively, with blue dye (p-values for each analysis <0.0001). Table 2: Distribution of Patients with at Least One Confirmed Unilateral Lymph Node/ Bilateral Pair Detected by Indocyanine Green or Blue Dye (BD) *: patients with at least one resected confirmed lymph node detected unilaterally **: patients with at least one resected confirmed lymph node detected bilaterally Analysis Population Patients (n) Patients with All Lymph Nodes Detected with Indocyanine Green Patients with All Lymph Nodes Detected with BD Patients with Lymph Nodes Detected with Indocyanine Green only Patients with Lymph Nodes Detected with BD only Patients with Lymph Nodes Detected with Neither mlTT Unilateral* 172 (167/172) 97% (118/172) 68% (51/172) 30% (2/172) 1% (3/172) 3% mlTT Bilateral** (126/172) 73% (49/172) 28% (79/172) 46% (2/172) 1% (44/172) 26%

🧪 Nonclinical Toxicology 28 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the potential for carcinogenicity, mutagenicity, or impairment of fertility by indocyanine green.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the potential for carcinogenicity, mutagenicity, or impairment of fertility by indocyanine green.

📄 Recent Major Changes 53 words ▾

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

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - Vial Vial Label NDC 70100-424-01 Rx only Sterile Indocyanine Green for Injection, USP 25 mg/Vial Single-Patient-Use For Intravenous or Interstitial Use After reconstitution, use within 6 hours. Distributed by: Diagnostic Green LLC 50428 01/2025 Lot No. Exp.: Principal Display Panel - Vial

PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL Sterile Water Label 10 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE Rx only NDC 0409-4887-17 Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Do not give intravenously unless rendered nearly isotonic. Hospira, Inc. RL-4428 Lake Forest, IL 60045 USA Principal Display Panel - Sterile Water Label

PRINCIPAL DISPLAY PANEL - Carton Carton Label NDC 70100-424-02 Rx Only - Sterile Indocyanine Green for Injection, USP 25 mg/Vial Single-Patient-Use For Intravenous or Interstitial Use Distributed by: Diagnostic Green LLC Back Panel NDC 70100-424-02 Rx Only - Sterile Recommended Dosage and Reconstitution Instructions: See Prescribing Information Use within 6 hours after reconstitution. STORAGE: Store at 20° to 25° C (68° to 77°F) KIT CONTAINS: • Six vials of Indocyanine Green (25 mg each) • Six Sterile Water for Injection (10 mL each) Indocyanine Green for Injection, USP 25 mg/Vial Single-Patient-Use For Intravenous or Interstitial Use Left Panel Indocyanine Green for Injection, USP Distributed by: Diagnostic Green LLC Farmington Hills MI 48331 USA Manufactured by: Patheon Italia S.p.A.

20052 Monza (Milano) ITALY or Lyocontract GmbH 38871 Ilsenburg GERMANY Sterile Water Manufactured by: Hospira, Inc. Rocky Mount, NC 27804 or Fresenius Kabi USA, LLC Grand Island, NY 14072 or Hikma Pharmaceuticals Berkeley Heights, NJ 07922 01/2025 Principal Display Panel - Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Renew Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Renew Pharmaceuticals Limited 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.
← 70095-0218-11 · SUN 70100-0810-02 · Renew →
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.