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United States · US · US:51862-462_2a3303f1-eee7-4c07-9532-e153be149369
Tolsura
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma Commercial LLC
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11518624626060 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
N208901
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": {
"306352d1-9d5a-49ad-b72d-893b99546861": {
"match": "brand_token",
"title": "TOLSURA (ITRACONAZOLE) CAPSULE, GELATIN COATED [MAYNE PHARMA COMMERCIAL LLC]",
"spl_version": "10",
"published_date": "2025-04-25"
}
},
"productid": "51862-462_2a3303f1-eee7-4c07-9532-e153be149369",
"productndc": "51862-462",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "208901",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "65MG",
"product_no": "001",
"approval_date": "Dec 11, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ITRACONAZOLE",
"shortage_reason": "Itraconazole Capsule",
"shortage_status": "current",
"proprietary_name": "Tolsura",
"active_ingred_unit": "mg/1",
"application_number": "NDA208901",
"marketing_category": "NDA",
"nonproprietary_name": "Itraconazole",
"start_marketing_date": "20181211",
"active_numerator_strength": "65"
}Related drugs
Other records sharing ATC code J02AC02.
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