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United States · US · US:13668-463_190020d3-1073-4c51-a948-ed1e371b72ea
Itraconazole
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111366846305500 CAPSULE in 1 BOTTLE (13668-463-05)
- ndc11136684633030 CAPSULE in 1 BOTTLE (13668-463-30)
- ndc11136684633728 CAPSULE in 1 CARTON (13668-463-37)
- ndc11136684639090 CAPSULE in 1 BOTTLE (13668-463-90)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A209460
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": "13668-463_190020d3-1073-4c51-a948-ed1e371b72ea",
"productndc": "13668-463",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209460",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 24, 2018"
}
],
"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": "ANDA209460",
"marketing_category": "ANDA",
"nonproprietary_name": "Itraconazole",
"start_marketing_date": "20180824",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC02.
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