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United States · US · US:70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4

POSACONAZOLE

In shortageOrange BookUNIISPLATC J02AC04

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

Identification

ManufacturerBiocon Phama Inc.
CountryUS (United States)
ATC codeJ02AC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7037703811
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)

Annotations

UNII (FDA Substance ID)
6TK1G07BHZ
POSACONAZOLE
RxCUI 282446
Orange Book
A214476
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": "70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4",
  "productndc": "70377-038",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "214476",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 4, 2022"
      }
    ],
    "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": "ANDA214476",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Posaconazole",
  "start_marketing_date": "20220308",
  "active_numerator_strength": "100"
}

Related drugs

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