Medicine
Methylene blue 100 mg/10 mL injection
Methylene blue 100 mg/10 mL injection is a generic prescription medicine for intravenous use, 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
- Sold under the generic name
- Strength
- 100 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL, 5 vials of 10 mL and 1 more
- Manufacturer
- Zydus LifesciencesIndia
- 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 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
- 1 April 2026
- Identifiers
- RxCUI 1737852, 1788984, 2199323DailyMed set ID df3568d6-d509-4c93-9a92-0e3d1d8514dc, 8c56fbad-a449-4ed4-a55f-1694e4e8e26aNDC 70771-1963, 70710-2083Application ANDA215636
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 |
|---|---|---|---|
| 1 vial in 1 carton / 10 mL in 1 vial | 70710-2083-1 | Zydus LifesciencesIndia | 1 April 2026 |
| 5 vial in 1 carton / 10 mL in 1 vial | 70710-2083-5 | Zydus LifesciencesIndia | 1 April 2026 |
| 1 vial in 1 carton / 10 mL in 1 vial | 70771-1963-1 | Zydus LifesciencesIndia | 1 April 2026 |
| 5 vial in 1 carton / 10 mL in 1 vial | 70771-1963-5 | Zydus LifesciencesIndia | 1 April 2026 |
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
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 Methylene blue 100 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.