United States· US:68462-698_eec9bc86-b15b-4c0c-a669-65b03b73da0b
METHYLENE BLUE
A medicinal product containing methylene blue, registered in United States by GLENMARK PHARMACEUTICALS INC., USA.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- METHYLENE BLUE
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168462-698-15
- ndc1168462698155 VIAL, SINGLE-DOSE in 1 CARTON (68462-698-15) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Methylene blue in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomMethylthioninium chloride (methylene blue) 100mg/10ml solution for injection ampoulesMartindale Pharmaceuticals Ltd
- BelgiumLumeblue 25 mgCosmo Technologies
- CanadaMETHYLENE BLEU LIQ 1%LABORATOIRE ATLAS INC
- CzechiaMETHYLTHIONINIUMCHLORID PROVEBLUEPROVEPHARM SAS, Marseille
- IrelandLumeblue 25 mg prolonged-release tabletsAlfasigma S.p.A
- FinlandLumeblueCosmo Technologies Limited
- SwedenMethylthioninium chloride Proveblue 5 mg/ml Injektionsvätska, lösningProvepharm SAS
- NorwayMetibloSterop
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Belgium · Metiblo
- United Kingdom (Northern Ireland) · Methylthioninium Chloride Phebra Limited
- Iceland · Proveblue
- Italy · Metiltioninio Cloruro Bioindustria L.I.M., Metiltioninio Cloruro Monico
- Liechtenstein · Proveblue
- Norway · Proveblue
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/095981c9-369e-4cb9-b30a-5e9984af2ff0 GET /v1/drugs/095981c9-369e-4cb9-b30a-5e9984af2ff0?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAVENOUS",
"source": "ndc",
"strength": "50",
"substance": "METHYLENE BLUE",
"productndc": "68462-698",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/10mL",
"application_number": "ANDA219550",
"marketing_category": "ANDA"
}See everything about methylene blue.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.