Itraconazole

In shortageOrange BookUNIISPLATC J02AC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeJ02AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787745405
500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05)
ndc11
6787745430
30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30)
ndc11
6787745484
3 BLISTER PACK in 1 CARTON (67877-454-84) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33)
ndc11
6787745490
90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90)

Annotations

UNII (FDA Substance ID)

304NUG5GF4

ITRACONAZOLE

RxCUI 28031

Orange Book

A208591

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": "67877-454_17ebcbb4-d52b-44b8-a4ef-42ddae5034db",
  "productndc": "67877-454",
  "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": "20170612",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J02AC02.

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