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United States · US · US:82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d
nitrofurantoin macrocrystals
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11828041311414 CAPSULE in 1 BOTTLE (82804-131-14)
- ndc11828041312020 CAPSULE in 1 BOTTLE (82804-131-20)
- ndc11828041312828 CAPSULE in 1 BOTTLE (82804-131-28)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A217272
ABABAB
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": "82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d",
"productndc": "82804-131",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217272",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 21, 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 macrocrystals",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217272",
"marketing_category": "ANDA",
"nonproprietary_name": "nitrofurantoin macrocrystals",
"start_marketing_date": "20230321",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01XE01.
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