Label: ETOPOSIDE injection

  • NDC Code(s): 16729-114-08, 16729-114-11, 16729-114-31, 16729-114-32
  • Packager: Accord Healthcare Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 29, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx ONLY - WARNINGS - Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with ...
  • DESCRIPTION
    Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin ...
  • CLINICAL PHARMACOLOGY
    Etoposide Injection USP has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Two different ...
  • INDICATIONS AND USAGE
    Etoposide Injection USP is indicated in the management of the following neoplasms: Refractory Testicular Tumors - Etoposide Injection USP in combination therapy with other approved ...
  • CONTRAINDICATIONS
    Etoposide Injection USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
  • WARNINGS
    Patients being treated with etoposide Injection USP must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported ...
  • PRECAUTIONS
    General - In all instances where the use of etoposide Injection USP is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse ...
  • ADVERSE REACTIONS
    The following data on adverse reactions are based on intravenous administration of etoposide Injection USP as a single agent, using several different dose schedules for treatment of a wide variety ...
  • OVERDOSAGE
    No proven antidotes have been established for etoposide Injection USP overdosage.
  • DOSAGE AND ADMINISTRATION
    Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with - undilutedEtoposide Injection ...
  • HOW SUPPLIED
    Etoposide Injection USP, 20 mg/mL, is supplied as follows: NDC 16729-114-31                  100 mg/5 mL Sterile, Multiple Dose Vial. NDC 16729-114-32                  250 mg/12.5 mL Sterile ...
  • REFERENCES
    Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC ...
  • PRINCIPAL DISPLAY PANEL-100 mg/5 mL Carton Label
    5ml Carton Label
  • PRINCIPAL DISPLAY PANEL-500 mg/12.5 mL Carton Label
    12.5 mL Carton Label
  • PRINCIPAL DISPLAY PANEL-500 mg/25 mL Carton Label
    25 mL Carton Label
  • PRINCIPAL DISPLAY PANEL-1 g/50 mL Carton Label
    50 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    Product Information