posaconazole

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

ManufacturerGLENMARK PHARMACEUTICALS INC., USA

CountryUS (United States)

ATC codeJ02AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846290401
1 VIAL in 1 CARTON (68462-904-01) / 16.7 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

6TK1G07BHZ

POSACONAZOLE

RxCUI 282446

Orange Book

A217553

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": "INTRAVENOUS",
  "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": "68462-904_1084301f-f51a-4bf5-8d37-bd779590d5e5",
  "productndc": "68462-904",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217553",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "300MG/16.7ML (18MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 26, 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/mL",
  "application_number": "ANDA217553",
  "marketing_category": "ANDA",
  "nonproprietary_name": "posaconazole",
  "start_marketing_date": "20231227",
  "active_numerator_strength": "18"
}

Related drugs

Other records sharing ATC code J02AC04.

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