CASPOFUNGIN ACETATE

In shortageOrange BookUNIISPLATC J02AX04

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

Identification

ManufacturerHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeJ02AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6589700021
1 VIAL, SINGLE-DOSE in 1 CARTON (65897-0002-1) / 10.8 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

VUW370O5QE

CASPOFUNGIN ACETATE

RxCUI 282363

Orange Book

A216506

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": "65897-0002_3fff89e8-9783-89fd-e063-6394a90a26ff",
  "productndc": "65897-0002",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "216506",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jul 18, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "70MG/VIAL",
        "product_no": "002",
        "approval_date": "Jul 18, 2025"
      }
    ],
    "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": "ANDA216506",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CASPOFUNGIN ACETATE",
  "start_marketing_date": "20250826",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code J02AX04.

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