Label: TESTOSTERONE / CHOLESTEROL pellet, implantable

  • NDC Code(s): 69761-420-06, 69761-420-12, 69761-420-30
  • 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 December 10, 2020

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  • DESCRIPTION

    estradiol 12mg pellet

  • PRINCIPAL DISPLAY PANEL

    420-01

    6-Pellet

    420-06

    12-Pellet

    420-12

    30-Pellet

    420-30

    res

  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE / CHOLESTEROL 
    testosterone / cholesterol pellet, implantable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69761-420
    Route of AdministrationPARENTERALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Product Characteristics
    Colorwhite (white to yellow) Score    
    ShapecapsuleSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69761-420-066 in 1 PACKAGE; Type 0: Not a Combination Product09/20/2020
    2NDC:69761-420-1212 in 1 PACKAGE; Type 0: Not a Combination Product09/20/2020
    3NDC:69761-420-3030 in 1 PACKAGE; Type 0: Not a Combination Product09/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2020
    Labeler - Qualgen LLC (034474862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qualgen LLC034474862manufacture(69761-420)