Data / Drug companies / Methylene blue
Methylene blue: 15 companies and 25 products in the FDA NDC directory
Methylene blue is listed in the FDA National Drug Code Directory by 15 companies, with 25 products in commercial distribution. 17 of the products (68.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution; solution, and the newest product started marketing on April 1, 2026.
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- Companies listing it
- 15
- Products
- 25
- Generic (ANDA) products
- 17 (68.0%)
- Application numbers
- 9
- Routes
- Intravenous, Extracorporeal
- Brand names
- Provayblue
- openFDA record search
- api.fda.gov
Companies that list methylene blue
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| American Regent, Inc. | 4 | injection | New drug applications (NDA) | April 8, 2020 |
| Zydus Lifesciences Limited | 3 | injection | Generic drugs (ANDA) | April 1, 2026 |
| Zydus Pharmaceuticals USA Inc. | 3 | injection | Generic drugs (ANDA) | April 1, 2026 |
| Amneal Pharmaceuticals LLC | 2 | injection, solution | Generic drugs (ANDA) | March 3, 2025 |
| Bpi Labs LLC | 2 | injection | Other unapproved drugs | May 15, 2023 |
| Steriscience Specialties Private Limited | 2 | injection, solution | Generic drugs (ANDA) | January 7, 2026 |
| Beijing Junge Technology Co., Ltd. | 1 | solution | Over the counter monograph drugs | January 10, 2025 |
| Chengdu Shuode Pharmaceutical Co., Ltd | 1 | injection | Generic drugs (ANDA) | December 23, 2025 |
| Fast Sold LLC | 1 | solution | Over the counter monograph drugs | December 1, 2024 |
| Glenmark Pharmaceuticals Inc., USA | 1 | injection | Generic drugs (ANDA) | December 23, 2025 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection, solution | Generic drugs (ANDA) | June 5, 2025 |
| Meitheal Pharmaceuticals Inc. | 1 | injection | Generic drugs (ANDA) | January 23, 2025 |
| Nexus Pharmaceuticals LLC | 1 | injection, solution | Generic drugs (ANDA) | February 1, 2025 |
| Olic (Thailand) Limited | 1 | injection, solution | Generic drugs (ANDA) | February 1, 2025 |
| Xiromed, LLC | 1 | injection | Generic drugs (ANDA) | September 28, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 16 | 64% |
| Injection, solution | 7 | 28% |
| Solution | 2 | 8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 17 | 68% |
| New drug applications (NDA) | 4 | 16% |
| Other unapproved drugs | 2 | 8% |
| Over the counter monograph drugs | 2 | 8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Oxidation-Reduction Agent | 25 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.