United States· US:70700-328_3eddefa4-0024-493a-e063-6294a90a1b49

METHYLENE BLUE

A antidotes product containing methylene blue, registered in United States by XIROMED, LLC. The same ATC class is registered in 7 of our 19 countries.

ATC V03ABOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMETHYLENE BLUEATCV03ABREGISTER NO.US:70700-328_3eddefa4…PACKS LISTED1CHECKEDJune 3, 2026

Where it is registered

Methylene blue is registered in 7 of 19 countries.

Countries holding a registration under ATC V03AB (antidotes), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Methylene blue · ATC V03AB

7 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Ireland
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
METHYLENE BLUE
Manufacturer
XIROMED, LLC
Country
United States (US)
ATC code
V03AB
ATC class
Antidotes
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    7070032824
    5 VIAL, SINGLE-DOSE in 1 CARTON (70700-328-24) / 10 mL in 1 VIAL, SINGLE-DOSE (70700-328-22)

Regulatory notes

UNII (FDA substance ID)
T42P99266K
METHYLENE BLUE
RxCUI 6878
Orange Book
A219363
AP
DailyMed SPL labels
1 version tracked

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.

All methylene blue products

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/c9f4bdad-9803-48ae-8351-84482b81af17
GET /v1/drugs/c9f4bdad-9803-48ae-8351-84482b81af17?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.

{
  "unii": {
    "unii": "T42P99266K",
    "rxcui": "6878",
    "inchikey": "XQAXGZLFSSPBMK-UHFFFAOYSA-M",
    "display_name": "METHYLENE BLUE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d115faab-577f-4299-87ed-8d4f909b4659": {
      "match": "brand_token",
      "title": "METHYLENE BLUE INJECTION, SOLUTION [OLIC (THAILAND) LIMITED]",
      "spl_version": "1",
      "published_date": "2026-04-17"
    }
  },
  "productid": "70700-328_3eddefa4-0024-493a-e063-6294a90a1b49",
  "productndc": "70700-328",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219363",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLENE BLUE",
  "proprietary_name": "METHYLENE BLUE",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA219363",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHYLENE BLUE",
  "start_marketing_date": "20250928",
  "active_numerator_strength": "50"
}

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.