ITRACONAZOLE

In shortageOrange BookUNIISPLATC J02AC02

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeJ02AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6233220404
28 CAPSULE in 1 CARTON (62332-204-04)
ndc11
6233220410
100 CAPSULE in 1 CARTON (62332-204-10)
ndc11
6233220430
30 CAPSULE in 1 BOTTLE (62332-204-30)
ndc11
6233220471
500 CAPSULE in 1 BOTTLE (62332-204-71)
ndc11
6233220490
90 CAPSULE in 1 BOTTLE (62332-204-90)

Annotations

UNII (FDA Substance ID)

304NUG5GF4

ITRACONAZOLE

RxCUI 28031

Orange Book

A206741

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": "62332-204_585449d8-bba8-44fb-9544-e83636d972e0",
  "productndc": "62332-204",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206741",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 13, 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": "ANDA206741",
  "marketing_category": "ANDA",
  "nonproprietary_name": "itraconazole",
  "start_marketing_date": "20161216",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J02AC02.

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