Label: TESTOSTERONE / ANASTROZOLE pellet

  • NDC Code(s): 69761-222-12, 69761-222-30
  • Packager: Qualgen LLC
  • 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 July 19, 2020

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

  • DESCRIPTION

    estradiol 12mg pellet

  • PRINCIPAL DISPLAY PANEL

    12-Pellet

    T-A 222-12

    30-Pellet

    T-A 222-30

    res

  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE / ANASTROZOLE 
    testosterone / anastrozole pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69761-222
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ) ANASTROZOLE20 mg
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69761-222-1212 in 1 PACKAGE; Type 0: Not a Combination Product11/14/2017
    2NDC:69761-222-3030 in 1 PACKAGE; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/14/2017
    Labeler - Qualgen LLC (034474862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qualgen LLC034474862manufacture(69761-222)