Drug
Who makes methylene blue?
13 companies list methylene blue as a human prescription drug, including under the names PROVAYBLUE. Forms: injection; injection, solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing methylene blue
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| American Regent, Inc.United States | injection | NDANDA204630 | 4 | 5 |
| Zydus Lifesciences LimitedIndia | injection | ANDAANDA215636 | 3 | 12 |
| Zydus Pharmaceuticals USA Inc.India | injection | ANDAANDA215636 | 3 | 1 |
| BPI Labs, DBA Ally LabsUnited States | injection | UNAPPROVED DRUG OTHER | 2 | 2 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA216955 | 2 | 1 |
| STERISCIENCE SP Z O OPoland | injection, solution | ANDAANDA216955 | 2 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection | ANDAANDA219550 | 1 | 9 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA216959 | 1 | 4 |
| Chengdu Shuode Pharmaceutical Co.,LtdChina | injection | ANDAANDA219550 | 1 | 1 |
| Nexus Pharmaceuticals, LLCUnited States | injection, solution | ANDAANDA217561 | 1 | 1 |
| OLIC (Thailand) LimitedThailand | injection, solution | ANDAANDA217561 | 1 | 1 |
| Xiromed LLCIndia | injection | ANDAANDA219363 | 1 | 1 |
| Meitheal Pharmaceuticals, Inc. | injection | ANDAANDA217380 | 1 | 0 |
Bulk ingredient listings
- MACSEN DRUGSIndia · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- SCH Global Services Private Limited · 2 NDC
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Aktinos pharma Private Limited · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Cutyx Research LLPIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- KALINTIS HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- NuCare Pharmaceuticals,Inc.United States · 1 NDC
- Pharmazell (India) Private LimitedIndia · 1 NDC
- SHOOLIN PHARMA CHEM LLPIndia · 1 NDC
- Shandong Keyuan Pharmaceutical Co.,Ltd.China · 1 NDC
- Sichuan Qingmu Pharmaceutical Co., Ltd.China · 1 NDC
- Tianjin Weijie Pharmaceutical Co., Ltd.China · 1 NDC
Enquiry
Common questions
- Who makes methylene blue?
- 13 companies list methylene blue as a human prescription drug in the openFDA NDC Directory, led by American Regent, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., BPI Labs, DBA Ally Labs, Amneal Ireland Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic PROVAYBLUE?
- 11 companies list methylene blue under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies methylene blue active ingredient?
- 17 companies list methylene blue as a bulk ingredient, including MACSEN DRUGS, Professional Compounding Centers of America dba PCCA, SCH Global Services Private Limited, AZICO BIOPHORE INDIA PRIVATE LIMITED.