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United States · US · US:16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a
Nitrofurantoin
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116571888061 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N009175
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": "16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a",
"productndc": "16571-888",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "009175",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/5ML",
"product_no": "002",
"approval_date": "Jun 9, 2023"
}
],
"appl_type": "N"
},
"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": "NDA009175",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Nitrofurantoin",
"start_marketing_date": "20240201",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01XE01.
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