Medicine
Methylene blue 50 mg/10 mL injection
Methylene blue 50 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 10 labelers, 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
- 50 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 ampules of 10 mL, 5 syringes of 10 mL, 5 vials of 10 mL and 10 more
- Manufacturers
- Steriscience SpecialtiesIndiaZydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaAmneal PharmaceuticalsChengdu Shuode PharmaceuticalHikma PharmaceuticalsMeitheal PharmaceuticalsNexus PharmaceuticalsOLIC (Thailand)Xiromed
- 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 pre-filled syringe 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
- 5 December 2023
- Identifiers
- RxCUI 1788984, 2731634, 1737852 +1DailyMed set ID eb87d31c-3a8e-4089-9693-20bc17279650, 67da2a69-8166-46c7-921c-d6ec47bfeac8, df3568d6-d509-4c93-9a92-0e3d1d8514dc +8NDC 82449-003, 70121-2716, 70771-1768 +10Application ANDA216955, ANDA215636, ANDA217561 +4
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 ampule in 1 carton / 10 mL in 1 ampule | 82449-002-06 | Steriscience SpecialtiesIndia | 28 February 2025 |
| 5 syringe in 1 carton / 10 mL in 1 syringe | 82449-003-06 | Steriscience SpecialtiesIndia | 7 January 2026 |
| 5 vial in 1 carton / 10 mL in 1 vial | 70710-1838-5 | Zydus LifesciencesIndia | 5 December 2023 |
| 5 vial in 1 carton / 10 mL in 1 vial | 70771-1768-5 | Zydus LifesciencesIndia | 5 December 2023 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 68462-698-15 | Glenmark PharmaceuticalsIndia | 23 December 2025 |
| 10 ampule in 1 box / 10 mL in 1 ampule | 70121-2715-2 | Amneal Pharmaceuticals | 3 March 2025 |
| 5 syringe in 1 box / 10 mL in 1 syringe | 70121-2716-2 | Amneal Pharmaceuticals | 3 March 2025 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 82432-104-02 | Chengdu Shuode Pharmaceutical | 23 December 2025 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0143-9094-05 | Hikma Pharmaceuticals | 5 June 2025 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-811-11 | Meitheal Pharmaceuticals | 23 January 2025 |
| 5 vial, glass in 1 carton / 10 mL in 1 vial, glass | 14789-119-05 | Nexus Pharmaceuticals | 1 February 2025 |
| 5 vial, glass in 1 carton / 10 mL in 1 vial, glass | 15243-344-05 | OLIC (Thailand) | 1 February 2025 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 70700-328-24 | Xiromed | 28 September 2025 |
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 Methylene blue 50 mg/10 mL injection for your hospital or patient?
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