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United States · US · US:54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735
Nitrofurantoin Mono
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmPak, Inc.
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1154348849061 BOTTLE in 1 BOX (54348-849-06) / 6 CAPSULE in 1 BOTTLE
- ndc1154348849101 BOTTLE in 1 BOX (54348-849-10) / 10 CAPSULE in 1 BOTTLE
- ndc1154348849141 BOTTLE in 1 BOX (54348-849-14) / 14 CAPSULE in 1 BOTTLE
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": "54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735",
"productndc": "54348-849",
"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 Mono",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020064",
"marketing_category": "NDA",
"nonproprietary_name": "NITROFURANTOIN MONOHYDRATE",
"start_marketing_date": "20190710",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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