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United States · US · US:72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1
NITROFURANTOIN
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirectrx
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11721891791010 CAPSULE in 1 BOTTLE (72189-179-10)
- ndc11721891791414 CAPSULE in 1 BOTTLE (72189-179-14)
- ndc11721891792020 CAPSULE in 1 BOTTLE (72189-179-20)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A077066
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "927AH8112L",
"rxcui": "7454",
"inchikey": "NXFQHRVNIOXGAQ-YCRREMRBSA-N",
"display_name": "NITROFURANTOIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"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": "72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1",
"productndc": "72189-179",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077066",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Apr 5, 2005"
}
],
"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": "ANDA077066",
"marketing_category": "ANDA",
"nonproprietary_name": "NITROFURANTOIN",
"start_marketing_date": "20220118",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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