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United States · US · US:59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09
Nitrofurantoin
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651206231 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
E1QI2CQQ1I
NITROFURANTOIN MONOHYDRATE
RxCUI 221129
Orange Book
A212607
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nitrofurantoin Oral Suspension
Raw payload (JSON)
{
"unii": {
"unii": "E1QI2CQQ1I",
"rxcui": "221129",
"inchikey": "NHBPVLAHAVEISO-JSGFVSQVSA-N",
"display_name": "NITROFURANTOIN MONOHYDRATE",
"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": "59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09",
"productndc": "59651-206",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "212607",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "May 11, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN MONOHYDRATE",
"shortage_reason": "Nitrofurantoin Oral Suspension",
"shortage_status": "current",
"proprietary_name": "Nitrofurantoin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA212607",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin",
"start_marketing_date": "20230511",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01XE01.
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