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United States · US · US:67046-1271_508816c3-8864-38db-e063-6394a90a4b34
Nitrofurantoin (monohydrate/macrocrystals)
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461271330 CAPSULE in 1 BLISTER PACK (67046-1271-3)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A217357
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": "67046-1271_508816c3-8864-38db-e063-6394a90a4b34",
"productndc": "67046-1271",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217357",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Jul 11, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"proprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA217357",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20260428",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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