Quick answers
- What is Methylene blue used for?
- The FDA-approved label (Provayblue, American Regent, Inc., May 28, 2025) says: “PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methylene blue have a boxed warning?
- Yes. The FDA label for Provayblue has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methylene blue?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methylene blue been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methylene blue?
- 12 companies list prescription products of Methylene blue in the FDA NDC Directory, including American Regent, Inc., Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited.
What Methylene blue is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
— FDA label: Provayblue, American Regent, Inc., effective May 28, 2025. Read the full label on DailyMed →
The FDA has 12 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.
This label has a boxed warning. Read it on the full label →
11 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 21 in the FDA NDC Directory |
| Brand names | Provayblue |
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.
- American Regent, Inc.4 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Steriscience Specialties Private Limited2 products
- Amneal Pharmaceuticals LLC2 products
- Glenmark Pharmaceuticals Inc., USA1 product
- Chengdu Shuode Pharmaceutical Co., Ltd1 product
- Xiromed, LLC1 product
- OLIC (Thailand) Limited1 product
- Nexus Pharmaceuticals LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204630 PROVAYBLUE | Provepharm Sas | April 8, 2016 | 12, latest December 2, 2024 2024: Labeling · 2024: Labeling · 2024: Efficacy |
Generic approvals (7)
- ANDA215636Zydus Lifesciences · December 5, 2023
- ANDA217561Nexus · November 21, 2024
- ANDA216955Steriscience · November 22, 2024
- ANDA216959Hikma · December 17, 2024
- ANDA217380Meitheal · January 23, 2025
- ANDA219363Xiromed · July 30, 2025
- ANDA219550Chengdu Shuode · December 23, 2025
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Provayblue, American Regent, Inc., effective May 28, 2025; 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 →