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United States· US:50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058

NITROFURANTOIN

A nitrofuran derivatives product containing nitrofurantoin (monohydrate/macrocrystals), registered in United States by A-S Medication Solutions.

ATC J01XEOrange 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…normalisedNITROFURANTOINATCJ01XEREGISTER NO.US:50090-6664_41c1cb5…PACKS LISTED3CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about nitrofurantoin (monohydrate/macrocrystals)Answers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Nitrofurantoin (monohydrate/macrocrystals)
Manufacturer
A-S Medication Solutions
Country
United States (US)
ATC code
J01XE
ATC class
Nitrofuran derivatives
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 3

  • ndc11
    5009066640
    14 CAPSULE in 1 BOTTLE (50090-6664-0)
  • ndc11
    5009066641
    10 CAPSULE in 1 BOTTLE (50090-6664-1)
  • ndc11
    5009066642
    6 CAPSULE in 1 BOTTLE (50090-6664-2)

Regulatory notes

UNII (FDA substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A211013
AB
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Nitrofurantoin (monohydrate/macrocrystals) in 15 other countries

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

All nitrofurantoin (monohydrate/macrocrystals) products

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/cde9496b-85ea-4c7b-8ed5-9fe8b9ce0a12
GET /v1/drugs/cde9496b-85ea-4c7b-8ed5-9fe8b9ce0a12?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": "927AH8112L",
    "rxcui": "7454",
    "inchikey": "NXFQHRVNIOXGAQ-YCRREMRBSA-N",
    "display_name": "NITROFURANTOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 1
  },
  "spl_meta": {
    "52eea406-abb9-2713-e063-6294a90a00c6": {
      "match": "brand_token",
      "title": "NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058",
  "productndc": "50090-6664",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211013",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;25MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
  "proprietary_name": "NITROFURANTOIN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
  "start_marketing_date": "20220222",
  "active_numerator_strength": "25; 75"
}
API referenceMCP serverPlans

See everything about nitrofurantoin (monohydrate/macrocrystals).

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.

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