Back to search
🇺🇸

United States · US · US:69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d

Itraconazole Oral

In shortageOrange BookUNIISPLATC J02AC02

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

Identification

ManufacturerNatco Pharma USA LLC
CountryUS (United States)
ATC codeJ02AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6933915917
    40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)

Annotations

UNII (FDA Substance ID)
304NUG5GF4
ITRACONAZOLE
RxCUI 28031
Orange Book
A212239
AA
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": "69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d",
  "productndc": "69339-159",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212239",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Sep 1, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ITRACONAZOLE",
  "shortage_reason": "Itraconazole Capsule",
  "shortage_status": "current",
  "proprietary_name": "Itraconazole Oral",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Itraconazole",
  "start_marketing_date": "20220425",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code J02AC02.

Access this data programmatically

Query Itraconazole Oral 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.