United States· US:0054-0166_96ad05fd-dd3d-4c3c-9bc2-cafbfed2cb65
Mycophenolate Mofetil
A medicinal product containing mycophenolate mofetil, registered in United States by Hikma Pharmaceuticals USA Inc..
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
- MYCOPHENOLATE MOFETIL
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- 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
- ndc110054-0166-25
- ndc110054-0166-29
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mycophenolate mofetil in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomArzip 500mg tabletsZentiva Pharma UK Ltd
- CanadaACH-MYCOPHENOLATEACCORD HEALTHCARE INC
- FranceMYFENAX 500 mg, comprimé pelliculéTEVA (PAYS-BAS)
- NorwayCellCeptRoche
- CzechiaCELLCEPTRoche Registration GmbH, Grenzach-Wyhlen
- FinlandCellceptRoche Registration GmbH
- SwedenCellCept 1 g/5 ml Pulver till oral suspensionRoche Registration GmbH
- IrelandCellCept 1 g/5 ml Powder for oral suspensionRoche Registration GmbH
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Mowel, Mycophenolat Mofetil Sandoz
- Belgium · Mycophenolat Mofetil Sandoz
- Bulgaria · Микофенолат Мофетил Акорд
- Czechia · Mycophenolat Mofetil Sandoz
- Germany · Mowel, Mycophenolat 1 A Pharma
- Denmark · Mycophenolate Mofetil Hexal, Mycophenolatmofetil Accord
- Estonia · Mycophenolate Mofetil Accord
- Spain · Micofenolato De Mofetilo Accord, Micofenolato De Mofetilo Aristo
- Finland · Mycophenolate Mofetil Accord, Mycophenolate Mofetil Eql Pharma
- France · Mycophenolate Mofetil Arrow, Mycophenolate Mofetil Biogaran
- United Kingdom (Northern Ireland) · Mycophenolate Hexal, Mycophenolate Mofetil
- Croatia · Mofetilmikofenolat Tillomed, Trixin
- Ireland · Mycolat, Mycophenolate Mofetil Accord
- Iceland · Cellcept, Myclausen
- Italy · Micofenolato Mofetile Accord, Micofenolato Mofetile Ahcl
- Liechtenstein · Cellcept, Myclausen
- Lithuania · Mycophenolate Mofetil Accord
- Latvia · Mycophenolate Mofetil Accord
- Malta · Mycophenolate Mofetil Ascend
- Netherlands · Mycofenolaat Mofetil Accord, Mycofenolaat Mofetil Sandoz
- Norway · Cellcept, Myclausen
- Poland · Mycofit, Mycophenolate Mofetil Sandoz
- Portugal · Micofenolato De Mofetil Accord, Micofenolato De Mofetil Aristo
- Romania · Micofenolat Mofetil Sandoz
- Sweden · Mycophenolate Mofetil Accord, Mycophenolate Mofetil Eql Pharma
- Slovakia · Mykofenolát Mofetil Sandoz
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/c27bb461-0ceb-4db2-8125-e4ad89cc3be4 GET /v1/drugs/c27bb461-0ceb-4db2-8125-e4ad89cc3be4?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": "ORAL",
"source": "ndc",
"strength": "500",
"substance": "MYCOPHENOLATE MOFETIL",
"productndc": "0054-0166",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA065413",
"marketing_category": "ANDA"
}See everything about mycophenolate mofetil.
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.