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United States · US · US:71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5
Nitrofurantoin
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc1171335232006 CAPSULE in 1 BOTTLE (71335-2320-0)
- ndc11713352320120 CAPSULE in 1 BOTTLE (71335-2320-1)
- ndc11713352320214 CAPSULE in 1 BOTTLE (71335-2320-2)
- ndc11713352320330 CAPSULE in 1 BOTTLE (71335-2320-3)
- ndc11713352320428 CAPSULE in 1 BOTTLE (71335-2320-4)
- ndc11713352320560 CAPSULE in 1 BOTTLE (71335-2320-5)
- ndc11713352320610 CAPSULE in 1 BOTTLE (71335-2320-6)
- ndc11713352320790 CAPSULE in 1 BOTTLE (71335-2320-7)
- ndc11713352320821 CAPSULE in 1 BOTTLE (71335-2320-8)
- ndc1171335232098 CAPSULE in 1 BOTTLE (71335-2320-9)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A208516
AB
DailyMed SPL labels
1 version tracked
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": "71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5",
"productndc": "71335-2320",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208516",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "May 24, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"proprietary_name": "Nitrofurantoin",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208516",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin",
"start_marketing_date": "20180101",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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