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United States · US · US:63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8
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
- ndc1163629174806 CAPSULE in 1 BOTTLE (63629-1748-0)
- ndc11636291748120 CAPSULE in 1 BOTTLE (63629-1748-1)
- ndc11636291748214 CAPSULE in 1 BOTTLE (63629-1748-2)
- ndc11636291748330 CAPSULE in 1 BOTTLE (63629-1748-3)
- ndc11636291748428 CAPSULE in 1 BOTTLE (63629-1748-4)
- ndc11636291748560 CAPSULE in 1 BOTTLE (63629-1748-5)
- ndc11636291748610 CAPSULE in 1 BOTTLE (63629-1748-6)
- ndc11636291748790 CAPSULE in 1 BOTTLE (63629-1748-7)
- ndc11636291748821 CAPSULE in 1 BOTTLE (63629-1748-8)
- ndc1163629174898 CAPSULE in 1 BOTTLE (63629-1748-9)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A077066
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": "63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8",
"productndc": "63629-1748",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077066",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Apr 5, 2005"
}
],
"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": "ANDA077066",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20050406",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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