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United States · US · US:68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd
nitrofurantoin macrocrystals
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116838255901100 CAPSULE in 1 BOTTLE (68382-559-01)
- ndc1168382559101000 CAPSULE in 1 BOTTLE (68382-559-10)
- ndc11683825593010 BLISTER PACK in 1 CARTON (68382-559-30) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A205005
ABAB
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": "68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd",
"productndc": "68382-559",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205005",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 12, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Dec 12, 2017"
}
],
"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 macrocrystals",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205005",
"marketing_category": "ANDA",
"nonproprietary_name": "nitrofurantoin macrocrystals",
"start_marketing_date": "20180215",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01XE01.
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