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United States · US · US:57664-232_4ed13848-1151-c63a-e063-6394a90a3a05
Nitrofurantion
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157664232181000 CAPSULE in 1 BOTTLE (57664-232-18)
- ndc115766423288100 CAPSULE in 1 BOTTLE (57664-232-88)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A201722
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": {
"05f25774-f56a-48ef-bac3-8af663f8581a": {
"match": "brand_token",
"title": "NITROFURANTION CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "5",
"published_date": "2026-04-08"
}
},
"productid": "57664-232_4ed13848-1151-c63a-e063-6394a90a3a05",
"productndc": "57664-232",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "201722",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Feb 16, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "002",
"approval_date": "Feb 16, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "003",
"approval_date": "Feb 16, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN",
"shortage_reason": "Nitrofurantoin Oral Suspension",
"shortage_status": "current",
"proprietary_name": "Nitrofurantion",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201722",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantion",
"start_marketing_date": "20160415",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01XE01.
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