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United States · US · US:47781-308_97785cf3-ab56-4697-3ab6-7451919d889a
nitrofurantoin macrocrystals
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlvogen Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114778130801100 CAPSULE in 1 BOTTLE, PLASTIC (47781-308-01)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N016620
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": "47781-308_97785cf3-ab56-4697-3ab6-7451919d889a",
"productndc": "47781-308",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "016620",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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 macrocrystals",
"active_ingred_unit": "mg/1",
"application_number": "NDA016620",
"marketing_category": "NDA",
"nonproprietary_name": "nitrofurantoin macrocrystals",
"start_marketing_date": "20100927",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01XE01.
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