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United States · US · US:71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef
Nitrofurantoin (monohydrate/macrocrystals)
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
- ndc1171335237706 CAPSULE in 1 BOTTLE (71335-2377-0)
- ndc11713352377120 CAPSULE in 1 BOTTLE (71335-2377-1)
- ndc11713352377214 CAPSULE in 1 BOTTLE (71335-2377-2)
- ndc11713352377330 CAPSULE in 1 BOTTLE (71335-2377-3)
- ndc11713352377428 CAPSULE in 1 BOTTLE (71335-2377-4)
- ndc11713352377560 CAPSULE in 1 BOTTLE (71335-2377-5)
- ndc11713352377610 CAPSULE in 1 BOTTLE (71335-2377-6)
- ndc11713352377790 CAPSULE in 1 BOTTLE (71335-2377-7)
- ndc11713352377821 CAPSULE in 1 BOTTLE (71335-2377-8)
- ndc1171335237798 CAPSULE in 1 BOTTLE (71335-2377-9)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A217357
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": "71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef",
"productndc": "71335-2377",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217357",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Jul 11, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"proprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA217357",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20230914",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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