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United States · US · US:72319-023_3249c585-7620-444f-e063-6294a90ae5ac

Posaconazole

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

Manufactureri3 Pharmaceuticals, LLC
CountryUS (United States)
ATC codeJ02AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7231902302
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02)

Annotations

UNII (FDA Substance ID)
6TK1G07BHZ
POSACONAZOLE
RxCUI 282446
Orange Book
A216488
AB
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": "72319-023_3249c585-7620-444f-e063-6294a90ae5ac",
  "productndc": "72319-023",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216488",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 28, 2023"
      }
    ],
    "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/1",
  "application_number": "ANDA216488",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Posaconazole",
  "start_marketing_date": "20230915",
  "active_numerator_strength": "100"
}

Related drugs

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