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United States · US · US:65162-630_14950f16-445f-4f48-871f-31bc5328d099
Itraconazole
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651626300330 CAPSULE in 1 BOTTLE (65162-630-03)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A205080
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": "65162-630_14950f16-445f-4f48-871f-31bc5328d099",
"productndc": "65162-630",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205080",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 26, 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": "ANDA205080",
"marketing_category": "ANDA",
"nonproprietary_name": "Itraconazole",
"start_marketing_date": "20160927",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC02.
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