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United States · US · US:50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058
NITROFURANTOIN
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500906664014 CAPSULE in 1 BOTTLE (50090-6664-0)
- ndc11500906664110 CAPSULE in 1 BOTTLE (50090-6664-1)
- ndc1150090666426 CAPSULE in 1 BOTTLE (50090-6664-2)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A211013
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": "50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058",
"productndc": "50090-6664",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211013",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Feb 18, 2022"
}
],
"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": "ANDA211013",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20220222",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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