🇺🇸
United States · US · US:70518-4026_507169f8-1c30-a0e1-e063-6294a90ad062
Nitrofurantoin (monohydrate/macrocrystals)
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11705184026010 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-0)
- ndc11705184026114 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-1)
- ndc11705184026230 CAPSULE in 1 BLISTER PACK (70518-4026-2)
- ndc11705184026450 POUCH in 1 BOX (70518-4026-4) / 1 CAPSULE in 1 POUCH (70518-4026-5)
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": "70518-4026_507169f8-1c30-a0e1-e063-6294a90ad062",
"productndc": "70518-4026",
"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": "20240221",
"active_numerator_strength": "25; 75"
}Related drugs
Other records sharing ATC code J01XE.
Access this data programmatically
Query Nitrofurantoin (monohydrate/macrocrystals) and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.