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United States · US · US:70069-829_40efa147-f323-4d77-9a88-227434ff84c3
Nitrofurantoin
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069829011 BOTTLE, GLASS in 1 CARTON (70069-829-01) / 230 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A208909
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nitrofurantoin Oral Suspension
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": "70069-829_40efa147-f323-4d77-9a88-227434ff84c3",
"productndc": "70069-829",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "208909",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Jan 14, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN",
"shortage_reason": "Nitrofurantoin Oral Suspension",
"shortage_status": "current",
"proprietary_name": "Nitrofurantoin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA208909",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin",
"start_marketing_date": "20250226",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01XE01.
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