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United States · US · US:82619-147_4f67eeb9-5a7a-3693-e063-6394a90a8655
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCreekwood Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc118261914701100 CAPSULE in 1 BOTTLE (82619-147-01)
- ndc118261914702500 CAPSULE in 1 BOTTLE (82619-147-02)
- ndc1182619147031 BLISTER PACK in 1 CARTON (82619-147-03) / 14 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A220269
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": "82619-147_4f67eeb9-5a7a-3693-e063-6394a90a8655",
"productndc": "82619-147",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "220269",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;25MG",
"product_no": "001",
"approval_date": "Apr 7, 2026"
}
],
"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": "ANDA220269",
"marketing_category": "ANDA",
"nonproprietary_name": "Nitrofurantoin (monohydrate/macrocrystals)",
"start_marketing_date": "20260420",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
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