🇺🇸
United States · US · US:0615-8531_b8cd8a42-7614-4082-885c-ef2baf8ff2a5
NITROFURANTOIN (monohydrate/macrocrystals)
Orange BookUNIISPLATC J01XE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeJ01XE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11061585311010 CAPSULE in 1 BLISTER PACK (0615-8531-10)
- ndc11061585311414 CAPSULE in 1 BLISTER PACK (0615-8531-14)
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": "0615-8531_b8cd8a42-7614-4082-885c-ef2baf8ff2a5",
"productndc": "0615-8531",
"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.
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.