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United States · US · US:16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7c
Itraconazole
In shortageOrange BookUNIISPLATC J02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116714743017 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK
- ndc11167147430230 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02)
Annotations
UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A208591
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": "16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7c",
"productndc": "16714-743",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "208591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 12, 2017"
}
],
"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": "ANDA208591",
"marketing_category": "ANDA",
"nonproprietary_name": "Itraconazole",
"start_marketing_date": "20170901",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC02.
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