Label: TESTOZOLE- testosterone,usp pellet, implantable

  • NDC Code(s): 57377-060-01
  • Packager: Advanced Pharmaceutical Technology, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 27, 2022

If you are a consumer or patient please visit this version.

  • Indication:

    Estrogen Receptor Positive Metastatic Breast Cancer

  • Usual Dosage:

    180mg Testosterone & 12mg of Anastrozole

  • CAUTION:

    Federal Law prohibits dispensing without prescription.

  • Storage:

    Store t controlled room temperature

  • Manufactured by:

    ADVANCED PHARMACEUTICAL TECHNOLOGY

    Phone: (914)358-5260

    Elmsford, NY 10523

  • Testozole (57377-060-01)

    Testozole

    Testozole

    3 Sterile Pellets

    For subcutaneous implantation

    Each pellet contains:

    60mg Testosterone

    4mg Anastrozole

    Caution:

    Federal Law prohibits dispensing without presciption.

    Store at controlled room temperature.

  • INGREDIENTS AND APPEARANCE
    TESTOZOLE 
    testosterone,usp pellet, implantable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57377-060
    Route of AdministrationSUBCUTANEOUSDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE60 mg
    ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ) ANASTROZOLE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57377-060-013 in 1 AMPULE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2021
    Labeler - Advanced Pharmaceutical Technology, Inc. (023237884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Pharmaceutical Technology, Inc.023237884manufacture(57377-060)