United States· US:46708-712_e98b2abd-8068-482e-9ce3-1ab262f0838e

METHOTREXATE

A medicinal product containing methotrexate sodium, registered in United States by Alembic Pharmaceuticals Limited.

US 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…normalisedMETHOTREXATEATC—REGISTER NO.US:46708-712_e98b2abd…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
METHOTREXATE SODIUM
Manufacturer
Alembic Pharmaceuticals Limited
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

  • ndc11
    4670871201
    1 VIAL, SINGLE-DOSE in 1 CARTON (46708-712-01) / 40 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    46708-712-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Methotrexate sodium in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All methotrexate sodium products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Ebetrexat, Methofill
  • Belgium · Basitrin, Emthexate
  • Bulgaria · Ebetrexat, Инжексат
  • Cyprus · Injexate, Methotrexate Accord
  • Czechia · Foxiemo, Injexate
  • Germany · Lantarel, Lantarel Fs
  • Denmark · Ebetrex, Emthexate
  • Estonia · Ebetrex, Metex
  • Spain · Bertanel, Imeth
  • Finland · Ebetrex, Injexate
  • France · Imenor, Imeth
  • United Kingdom (Northern Ireland) · Ebetrex, Injexate
  • Greece · Methobion, Methotrexate Pfizer
  • Croatia · Ebetrexat, Methofill
  • Hungary · Ebetrexat, Methofill
  • Ireland · Methofill, Methotrexate Abcur
  • Iceland · Jylamvo, Methotrexat Ebewe
  • Italy · Afslamet, Immutrex
  • Liechtenstein · Jylamvo, Nordimet
  • Lithuania · Ebetrexat, Metex
  • Luxembourg · Emthexate, Emthexate Teva Pharma
  • Latvia · Ebetrex, Metex
  • Malta · Methotrexate Aspire Pharma (Malta)
  • Netherlands · Basitrin, Ebetrex
  • Norway · Ebetrex, Jylamvo
  • Poland · Ebetrexat, Metex
  • Portugal · Fauldexato, Ledertrexato
  • Romania · Methotrexat Ebewe, Metorthrit
  • Sweden · Ebetrex, Injexate
  • Slovenia · Methofill, Metoject
  • Slovakia · Foxiemo, Injexate

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/eaa0b0bf-9736-4c44-aeeb-b1a0b93a086b
GET /v1/drugs/eaa0b0bf-9736-4c44-aeeb-b1a0b93a086b?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": "INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS",
  "source": "ndc",
  "strength": "25",
  "substance": "METHOTREXATE SODIUM",
  "productndc": "46708-712",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA220225",
  "marketing_category": "ANDA"
}

See everything about methotrexate sodium.

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.