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United States · US · US:50458-290_b5d1c275-8665-4f63-8232-e34a02c998c7
SPORANOX
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150458290013 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK
- ndc11504582900430 CAPSULE in 1 BOTTLE (50458-290-04)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
N020083
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Itraconazole Capsule
Raw payload (JSON)
{
"unii": {
"unii": "304NUG5GF4",
"rxcui": "28031",
"inchikey": "VHVPQPYKVGDNFY-DFMJLFEVSA-N;VHVPQPYKVGDNFY-TUJWMRSMSA-N",
"display_name": "ITRACONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a4d555fa-787c-40fb-bb7d-b0d4f7318fd0": {
"match": "brand_token",
"title": "SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.]",
"spl_version": "30",
"published_date": "2026-03-02"
}
},
"productid": "50458-290_b5d1c275-8665-4f63-8232-e34a02c998c7",
"productndc": "50458-290",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020083",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 11, 1992"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ITRACONAZOLE",
"shortage_reason": "Itraconazole Capsule",
"shortage_status": "current",
"proprietary_name": "SPORANOX",
"active_ingred_unit": "mg/1",
"application_number": "NDA020083",
"marketing_category": "NDA",
"nonproprietary_name": "ITRACONAZOLE",
"start_marketing_date": "19920911",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC02.
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