Drug Database
SearchDocsMCPUse casesPricingStatus
Log inGet an API key
Back to search
🇺🇸

United States · US · US:46708-204_13a86518-48bc-421b-ad49-c253bd65b488

ITRACONAZOLE

In shortageOrange BookUNIISPLATC J02AC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4670820404
    28 CAPSULE in 1 CARTON (46708-204-04)
  • ndc11
    4670820410
    100 CAPSULE in 1 CARTON (46708-204-10)
  • ndc11
    4670820430
    30 CAPSULE in 1 BOTTLE (46708-204-30)
  • ndc11
    4670820471
    500 CAPSULE in 1 BOTTLE (46708-204-71)
  • ndc11
    4670820490
    90 CAPSULE in 1 BOTTLE (46708-204-90)

Annotations

UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A206741
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": "46708-204_13a86518-48bc-421b-ad49-c253bd65b488",
  "productndc": "46708-204",
  "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.

Access this data programmatically

Query ITRACONAZOLE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API keyRead the API docs