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United States · US · US:59746-762_38cc0082-af69-4216-e063-6394a90a078c
NITROFURANTOIN (monohydrate/macrocrystals)
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJubilant Cadista Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115974676206100 CAPSULE in 1 BOTTLE (59746-762-06)
- ndc1159746762151000 CAPSULE in 1 BOTTLE (59746-762-15)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A211013
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": "59746-762_38cc0082-af69-4216-e063-6394a90a078c",
"productndc": "59746-762",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211013",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Feb 18, 2022"
}
],
"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": "ANDA211013",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20220222",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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