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United States · US · US:0781-3421_d70d52c0-6601-f632-e053-2995a90a9291

CASPOFUNGIN ACETATE

In shortageOrange BookUNIISPLATC J02AX04

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ02AX04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781342194
    1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3421-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3421-01)

Annotations

UNII (FDA Substance ID)
VUW370O5QE
CASPOFUNGIN ACETATE
RxCUI 282363
Orange Book
A200833
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Caspofungin Acetate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "VUW370O5QE",
    "rxcui": "282363",
    "inchikey": "OGUJBRYAAJYXQP-IJFZAWIJSA-N",
    "display_name": "CASPOFUNGIN ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e76d8d83-3691-451c-a32c-d91448c54d16": {
      "match": "brand_token",
      "title": "CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "7",
      "published_date": "2026-02-11"
    }
  },
  "productid": "0781-3421_d70d52c0-6601-f632-e053-2995a90a9291",
  "productndc": "0781-3421",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "200833",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 28, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "70MG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 28, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CASPOFUNGIN ACETATE",
  "shortage_reason": "Caspofungin Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "CASPOFUNGIN ACETATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA200833",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CASPOFUNGIN ACETATE",
  "start_marketing_date": "20180904",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code J02AX04.

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