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United States · US · US:68071-2363_4b353a66-abe4-a233-e063-6294a90a685d
Nitrofurantion
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11680712363714 CAPSULE in 1 BOTTLE (68071-2363-7)
- ndc11680712363828 CAPSULE in 1 BOTTLE (68071-2363-8)
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": "68071-2363_4b353a66-abe4-a233-e063-6294a90a685d",
"productndc": "68071-2363",
"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": "100"
}Related drugs
Other records sharing ATC code J01XE01.
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