United States· US:61919-021_397f7645-278c-731e-e063-6294a90a2d3f
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE
A medicinal product containing nitrofurantoin; nitrofurantoin monohydrate, registered in United States by Direct_Rx.
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
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Manufacturer
- Direct_Rx
- 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 · 6
- ndc1161919021022 CAPSULE in 1 BOTTLE (61919-021-02)
- ndc11619190211010 CAPSULE in 1 BOTTLE (61919-021-10)
- ndc11619190211414 CAPSULE in 1 BOTTLE (61919-021-14)
- ndc1161919-021-02
- ndc1161919-021-10
- ndc1161919-021-14
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nitrofurantoin; nitrofurantoin monohydrate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomFuradantin 100mg tabletsAdvanz Pharma
- CzechiaAURUVENLITcon Pharma SE, Praha 8
- CanadaAURO-NITROFURANTOIN BIDAURO PHARMA INC
- NetherlandsFuradantine MC 50 mg, capsulesAmdipharm Limited
- IrelandMacroBID 100mg Prolonged-Release CapsulesAmdipharm Limited
- NorwayFuradantinViatris AS
- BelgiumFuradantine MC 100 mgAmdipharm
- ItalyNEOFURADANTINGRUNENTHAL ITALIA S.R.L.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Furadantin Retard, Nitrofurantoin Agepha
- Belgium · Furadantine Mc, Nitrofurantoin Activase
- Bulgaria · Фуролин
- Cyprus · Furolin, Macrodantin
- Czechia · Nostiriazyn
- Germany · Furadantin Retard, Furadantin Rp
- Denmark · Foragen, Nitrofurantoin "eql Pharma"
- Estonia · Magromag, Nitrofurantoin Orifarm
- Spain · Furantoína
- Finland · Foragen, Furuti
- France · Furadantine
- United Kingdom (Northern Ireland) · Aratoin, Furadantin
- Greece · Furolin, Nitrofurantoin Iasis
- Croatia · Ninur, Nitrofurantoin Galenika
- Hungary · Nitrofurantoin Pharmsol, Nitrofurantoin-Chinoin
- Ireland · Macrobid, Macrodantin
- Iceland · Furadantin
- Italy · Furedan, Nitrofurantoina Doc
- Lithuania · Furadonins, Magromag
- Luxembourg · Furadantine Mc
- Latvia · Furadonīns, Magromag
- Malta · Furolin, Macrodantin
- Netherlands · Foragen, Furabid
- Norway · Foragen, Furadantin
- Portugal · Furadantina Mc, Nitrofurantoin Activase
- Romania · Furolin, Nitrofurantoina Arena
- Sweden · Foragen, Furadantin
- Slovenia · Macrobid, Nitrofurantoin Activase 100 Mg
- Slovakia · Nitrofurantoin Olikla, Nitrofurantoin Pharmevid
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/42714264-2dd9-4b32-bb19-90cfeee6d292 GET /v1/drugs/42714264-2dd9-4b32-bb19-90cfeee6d292?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": "25; 75",
"substance": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"productndc": "61919-021",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA020064",
"marketing_category": "NDA"
}See everything about nitrofurantoin; nitrofurantoin monohydrate.
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.