🇺🇸
United States · US · US:62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f
NITROFURANTOIN
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116233238931100 CAPSULE in 1 BOTTLE (62332-389-31)
- ndc1162332389911000 CAPSULE in 1 BOTTLE (62332-389-91)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A211935
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nitrofurantoin Oral Suspension
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": "62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f",
"productndc": "62332-389",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211935",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jun 25, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Jun 25, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Jun 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN",
"shortage_reason": "Nitrofurantoin Oral Suspension",
"shortage_status": "current",
"proprietary_name": "NITROFURANTOIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211935",
"marketing_category": "ANDA",
"nonproprietary_name": "NITROFURANTOIN",
"start_marketing_date": "20210701",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01XE01.
Access this data programmatically
Query NITROFURANTOIN 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.