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United States · US · US:61919-021_397f7645-278c-731e-e063-6294a90a2d3f
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1161919021022 CAPSULE in 1 BOTTLE (61919-021-02)
- ndc11619190211010 CAPSULE in 1 BOTTLE (61919-021-10)
- ndc11619190211414 CAPSULE in 1 BOTTLE (61919-021-14)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N020064
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": "61919-021_397f7645-278c-731e-e063-6294a90a2d3f",
"productndc": "61919-021",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020064",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Dec 24, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"proprietary_name": "NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020064",
"marketing_category": "NDA",
"nonproprietary_name": "NITROFURANTOIN MONOHYDRATE",
"start_marketing_date": "20190708",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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