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United States · US · US:70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b
Nitrofurantoin
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095449610230 mL in 1 BOTTLE (70954-496-10)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A216385
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": "70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b",
"productndc": "70954-496",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "216385",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Apr 14, 2023"
}
],
"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": "ANDA216385",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin",
"start_marketing_date": "20230417",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01XE01.
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