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United States · US · US:70518-0265_4e797ba8-c3db-0bd1-e063-6394a90a4f06
Nitrofurantoin Monohydrate/ Macrocrystalline
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705180265310 CAPSULE in 1 BOTTLE, PLASTIC (70518-0265-3)
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": "70518-0265_4e797ba8-c3db-0bd1-e063-6394a90a4f06",
"productndc": "70518-0265",
"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/Macrocrystalline",
"start_marketing_date": "20170228",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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