posaconazole

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ02AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054044949
1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

6TK1G07BHZ

POSACONAZOLE

RxCUI 282446

Orange Book

A208773

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Posaconazole Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "6TK1G07BHZ",
    "rxcui": "282446",
    "inchikey": "RAGOYPUPXAKGKH-XAKZXMRKSA-N",
    "display_name": "POSACONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "548124ce-8050-46a9-967b-ff23dfb18633": {
      "match": "brand_token",
      "title": "POSACONAZOLE TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2026-05-26"
    }
  },
  "productid": "0054-0449_216b2666-3f04-4cb4-acea-e73ed7037a10",
  "productndc": "0054-0449",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "208773",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "May 15, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POSACONAZOLE",
  "shortage_reason": "Posaconazole Injection",
  "shortage_status": "current",
  "proprietary_name": "posaconazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA208773",
  "marketing_category": "ANDA",
  "nonproprietary_name": "posaconazole",
  "start_marketing_date": "20230329",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code J02AC04.

Access this data programmatically

Query posaconazole 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 key Read the API docs