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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

  • ndc11
    1671474301
    7 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK
  • ndc11
    1671474302
    30 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

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