Quick answers
- What is Isosulfan blue used for?
- The FDA-approved label (Isosulfan Blue, Devatis, Inc., July 1, 2026) says: “Isosulfan blue injection 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isosulfan blue have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Isosulfan blue?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isosulfan blue been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isosulfan blue?
- 6 companies list prescription products of Isosulfan blue in the FDA NDC Directory, including Mylan Institutional LLC, Eugia US LLC and Meitheal Pharmaceuticals Inc..
What Isosulfan blue is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Isosulfan blue injection 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. …
— FDA label: Isosulfan Blue, Devatis, Inc., effective July 1, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 8 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Institutional LLC3 products
- Eugia US LLC2 products
- Meitheal Pharmaceuticals Inc.1 product
- Novadoz Pharmaceuticals LLC1 product
- Somerset Therapeutics, LLC1 product
- Devatis, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA090874Mylan Institutional · July 20, 2010
- ANDA206831Eugia Pharma · February 2, 2016
- ANDA210714Saba Ilay Sanayi · January 16, 2019
- ANDA210558Somerset Theraps LLC · July 12, 2019
- ANDA213130Meitheal · November 3, 2021
- ANDA216090Msn · September 16, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | aa6260da-0acd-4552-a215-07df8da1031c |
|---|---|
| FDA labels (SPL) | 8 |
| FDA applications | 6 ANDA |
| Active ingredients (FDA) | ISOSULFAN BLUE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isosulfan Blue, Devatis, Inc., effective July 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →