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United States · US · US:71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc
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 · 9
- ndc11713352255140 CAPSULE in 1 BOTTLE (71335-2255-1)
- ndc11713352255228 CAPSULE in 1 BOTTLE (71335-2255-2)
- ndc11713352255330 CAPSULE in 1 BOTTLE (71335-2255-3)
- ndc11713352255420 CAPSULE in 1 BOTTLE (71335-2255-4)
- ndc11713352255514 CAPSULE in 1 BOTTLE (71335-2255-5)
- ndc11713352255610 CAPSULE in 1 BOTTLE (71335-2255-6)
- ndc11713352255712 CAPSULE in 1 BOTTLE (71335-2255-7)
- ndc11713352255890 CAPSULE in 1 BOTTLE (71335-2255-8)
- ndc1171335225596 CAPSULE in 1 BOTTLE (71335-2255-9)
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": "71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc",
"productndc": "71335-2255",
"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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