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United States · US · US:71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a
nitrofurantoin macrocrystals
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11713352254128 CAPSULE in 1 BOTTLE (71335-2254-1)
- ndc11713352254240 CAPSULE in 1 BOTTLE (71335-2254-2)
- ndc11713352254320 CAPSULE in 1 BOTTLE (71335-2254-3)
- ndc11713352254490 CAPSULE in 1 BOTTLE (71335-2254-4)
- ndc11713352254530 CAPSULE in 1 BOTTLE (71335-2254-5)
- ndc11713352254612 CAPSULE in 1 BOTTLE (71335-2254-6)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
A217272
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": "71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a",
"productndc": "71335-2254",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217272",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Mar 21, 2023"
}
],
"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": "ANDA217272",
"marketing_category": "ANDA",
"nonproprietary_name": "nitrofurantoin macrocrystals",
"start_marketing_date": "20230321",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J01XE01.
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