Medicine
Provayblue 50 mg/10 mL injection
Provayblue 50 mg/10 mL injection is a prescription medicine containing Methylene blue for intravenous use, marketed by American Regent, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Methylene blue
- Brand
- Provayblue
- Strength
- 50 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 ampules of 10 mL, 5 vials of 10 mL
- Marketing authorisation holder
- American Regent
- Manufacturer
- American Regent
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep the ampule or the vial in the original package to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V03AB17 Methylene blue
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 April 2016
- Identifiers
- RxCUI 1788984, 1788989, 2199323 +1DailyMed set ID 4f6848e5-35ed-4046-b13c-3032b5ba3232NDC 0517-0381, 0517-0374Application NDA204630
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 ampule in 1 carton / 10 mL in 1 ampule | 0517-0374-05 | American Regent | 8 April 2016 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0517-0381-05 | American Regent | 31 December 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Methylene blue 50 mg/10 mL injection.
Other strengths and forms of Methylene blue
Clinical summary
Methylene blue is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. It is available as injection for intravenous use. MedsAcross supplies Methylene blue for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Methylene blueFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PROVAYBLUE prescribing information (American Regent) · U.S. National Library of Medicine, DailyMed
- Lumeblue (previously Methylthioninium chloride Cosmo): European public assessment report (EPAR) · European Medicines Agency
- Methylthioninium chloride Proveblue: European public assessment report (EPAR) · European Medicines Agency
Need Provayblue 50 mg/10 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.