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United States · US · US:71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc
Nitrofurantoin
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117120585200100 CAPSULE in 1 BOTTLE (71205-852-00)
- ndc11712058521010 CAPSULE in 1 BOTTLE (71205-852-10)
- ndc11712058521414 CAPSULE in 1 BOTTLE (71205-852-14)
- ndc11712058522020 CAPSULE in 1 BOTTLE (71205-852-20)
- ndc11712058523030 CAPSULE in 1 BOTTLE (71205-852-30)
- ndc117120585255500 CAPSULE in 1 BOTTLE (71205-852-55)
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": "71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc",
"productndc": "71205-852",
"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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