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United States · US · US:63187-245_63156793-74b0-444c-bb12-dbe7be60ec91
Nitrofurantion Macrocrystals
In shortageOrange BookUNIISPLATC J01XE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01XE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11631872451010 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10)
- ndc11631872451414 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14)
- ndc11631872452020 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20)
- ndc11631872452828 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28)
Annotations
UNII (FDA Substance ID)
927AH8112L
NITROFURANTOIN
RxCUI 7454
Orange Book
N016620
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": {
"05f25774-f56a-48ef-bac3-8af663f8581a": {
"match": "brand_token",
"title": "NITROFURANTION CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "5",
"published_date": "2026-04-08"
}
},
"productid": "63187-245_63156793-74b0-444c-bb12-dbe7be60ec91",
"productndc": "63187-245",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "016620",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NITROFURANTOIN",
"shortage_reason": "Nitrofurantoin Oral Suspension",
"shortage_status": "current",
"proprietary_name": "Nitrofurantion Macrocrystals",
"active_ingred_unit": "mg/1",
"application_number": "NDA016620",
"marketing_category": "NDA",
"nonproprietary_name": "Nitrofurantion Macrocrystals",
"start_marketing_date": "20100927",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01XE01.
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