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United States · US · US:16571-245_c7336946-9638-4837-9046-1aef77694672
Itraconazole
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11165712450330 CAPSULE in 1 BOTTLE (16571-245-03)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A205724
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": {
"68165d90-953c-e2f5-e053-2a91aa0ada25": {
"match": "brand_token",
"title": "ITRACONAZOLE CAPSULE [AVPAK]",
"spl_version": "17",
"published_date": "2026-01-12"
}
},
"productid": "16571-245_c7336946-9638-4837-9046-1aef77694672",
"productndc": "16571-245",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205724",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 13, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ITRACONAZOLE",
"shortage_reason": "Itraconazole Capsule",
"shortage_status": "current",
"proprietary_name": "Itraconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205724",
"marketing_category": "ANDA",
"nonproprietary_name": "Itraconazole",
"start_marketing_date": "20250203",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC02.
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