Prescription medicine
Isosulfan blue First approved as Lymphazurin
Isosulfan blue (Lymphazurin) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
Check it at the source: the isosulfan blue FDA label on DailyMed (effective December 15, 2025, Mylan Institutional LLC); the NDA 18310 record on Drugs@FDA; every isosulfan blue label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIsosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection.
Forms and strengths
- 10 mg/ml
- 50 mg/5ml
Injection (solution).
On the market
- Earliest approval on file
- July 29, 1981 Lymphazurin, Covidien; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first July 20, 2010; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 44 through July 30, 2026
What is isosulfan blue used for?
From the label: indications and usageIsosulfan blue injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities ( 1.1 ). 1.1 Lymphatic Vessel Delineation Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. […]
Source: FDA drug label (Isosulfan Blue), Mylan Institutional LLC, effective December 15, 2025 (SPL set 0391e544-3633-48df-9f3a-ed16183125b1), via openFDA; the full label on DailyMed
Is there a generic for isosulfan blue (Lymphazurin)?
The FDA approved the first generic isosulfan blue on July 20, 2010. 8 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists isosulfan blue from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1981 earliest approval on file
- 2010 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the isosulfan blue label say about other medicines?
The isosulfan blue label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lidocaine | warnings and precautions | Precipitation of Isosulfan Blue Injection 1% by Lidocaine The admixture of isosulfan blue injection 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4% to 9% drug complex. |
Source: FDA drug label (Isosulfan Blue), Mylan Institutional LLC, effective December 15, 2025 (SPL set 0391e544-3633-48df-9f3a-ed16183125b1), via openFDA; the full label on DailyMed
What do FAERS reports show for isosulfan blue?
The FDA Adverse Event Reporting System holds 44 reports that list isosulfan blue among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Isosulfan blue side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other