INDOCYANINE GREEN
INDOCYANINE GREEN is an FDA drug label for the active ingredient INDOCYANINE GREEN manufactured by Zydus Lifesciences Limited. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260804.
- Generic name
- INDOCYANINE GREEN
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- N/A
- Dosage form
- N/A
- NDC
- 70771-1961
- Application
- ANDA219139
- Label effective
- 20260804
About this product
INDOCYANINE GREEN is an FDA-registered drug product whose active ingredient is INDOCYANINE GREEN. It is labelled by Zydus Lifesciences Limited and marketed as a human prescription drug product. Identifiers on file: NDC 70771-1961, application ANDA219139, label effective 20260804. It is one of 3 FDA drug label records sharing the active ingredient INDOCYANINE GREEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing INDOCYANINE GREEN are most often described in connection with: fluorescence imaging, pediatric patients, blood flow, tissue perfusion, extrahepatic biliary, lymphatic mapping, uterine cancer, ophthalmic angiography. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
More products with the same ingredient
INDOCYANINE GREENHow products containing INDOCYANINE GREEN compare
FDA lists 3 drug label records with INDOCYANINE GREEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Sagent Pharmaceuticals | 1 |
| — | — | Zydus Lifesciences Limited | 1 |
| — | — | Zydus Pharmaceuticals USA Inc. | 1 |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0812-2023 | IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | Akorn, Inc. | Class II | Ongoing | 20230607 |
| D-0697-2017 | IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02 | Akorn, Inc. | Class III | Terminated | 20170517 |
| D-0362-2017 | Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Wells Pharmacy Network LLC | Class II | Terminated | 20170111 |
| D-1429-2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | Akorn, Inc. | Class III | Terminated | 20150923 |
| D-732-2015 | Indocyanine Green active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada | Attix Pharmaceuticals | Class II | Terminated | 20150429 |
Frequently asked questions
What is INDOCYANINE GREEN used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient INDOCYANINE GREEN describe it in connection with: fluorescence imaging, pediatric patients, blood flow, tissue perfusion, extrahepatic biliary, lymphatic mapping, uterine cancer, ophthalmic angiography. Check the specific product label or ask a prescriber before use.
Who makes INDOCYANINE GREEN?
Zydus Lifesciences Limited is the labeler of record for INDOCYANINE GREEN. 3 FDA label records share the active ingredient INDOCYANINE GREEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
Is INDOCYANINE GREEN prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing INDOCYANINE GREEN?
Yes. 3 FDA drug label records list INDOCYANINE GREEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has INDOCYANINE GREEN been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.