United States· US:63323-122_3d21237a-ef53-4592-bf06-0c739696203d
Methotrexate
A medicinal product containing methotrexate sodium, registered in United States by Fresenius Kabi USA, LLC.
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
- METHOTREXATE SODIUM
- Manufacturer
- Fresenius Kabi USA, LLC
- 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
- ndc1163323122501 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
- ndc1163323-122-50
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.
- CzechiaFOXIEMOeasyMed s.r.o., Praha 10
- United KingdomEbetrex 10mg/1ml solution for injection pre-filled syringesSandoz Ltd
- SwitzerlandJylamvo
- NetherlandsBasitrin 10 mg=0,267 ml, oplossing voor injectie in een voorgevulde spuit 37,5 mg/mlBasic Pharma Manufacturing B.V.
- BelgiumBasitrin 10 mgBasic Pharma Manufacturing
- SpainBERTANEL 10 mg/1 ml SOLUCION INYECTABLE EN JERINGA PRECARGADAEbewe Pharma Ges.M.B.H. Nfg.Kg
- SwedenEbetrex 2,5 mg TablettEBEWE Pharma Ges.m.b.H.Nfg.KG
- FinlandEbetrexEbewe Pharma Ges.m.b.H. Nfg.KG
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/e5433edf-4141-47c4-bb86-0b82315bbfa1 GET /v1/drugs/e5433edf-4141-47c4-bb86-0b82315bbfa1?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": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"source": "ndc",
"strength": "1",
"substance": "METHOTREXATE SODIUM",
"productndc": "63323-122",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "g/1",
"application_number": "ANDA040266",
"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.