Label: TESTOSTERONE 12.5 MG- testosterone pellet

  • NDC Code(s): 69761-112-12, 69761-112-30
  • 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 22, 2020

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  • DESCRIPTION

    testosterone 200mg pellet

  • Principal Display Package

    T12.5 112-12

    T12.5 112-30

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  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE 12.5 MG 
    testosterone pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69761-112
    Route of AdministrationSUBCUTANEOUSDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69761-112-1212 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
    2NDC:69761-112-3030 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2015
    Labeler - Qualgen LLC (034474862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qualgen LLC034474862manufacture(69761-112)