Label: ADDEX-1000- naltrexone pellet, implantable

  • NDC Code(s): 57377-010-00
  • Packager: Advanced Pharmaceutical Technology, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 27, 2020

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  • SPL UNCLASSIFIED SECTION

    Naltrexone- in sterile dispenser.

    Contains slow release Naltrexone 1 gram pellet. Each trocar contains 1 pellet of 1 gram Naltrexone base. This product is not validated to replace oral Naltrexone. Recommended dose of 1 pellet of 1 gram.

  • Caution:

    Not to be used in conjunction with oral Naltrexone. Must be given only by a trained physician. This product is for single use only and the trocar discarded. Federal Law prohibits dispensing without a prescription.

  • Do Not Use-

    if pouch is damaged or open since it will no longer be sterile.

  • STORAGE AND HANDLING

    STORE IN A COOL DRY PLACE. (TEMPERATURE NOT TO EXCEED 30 OC)

  • COMPONENTS

    Each pellet contains: 1 Gram Naltrexone.

    Plus Inactives: ethyl cellulose USP, polyvinyl pyrrolidone USP, stearic acid USP.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ADDEX-1000 
    naltrexone pellet, implantable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57377-010
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NALTREXONE (UNII: 5S6W795CQM) (NALTREXONE - UNII:5S6W795CQM) NALTREXONE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57377-010-001 in 1 AMPULE; Type 0: Not a Combination Product05/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/16/2018
    Labeler - Advanced Pharmaceutical Technology, Inc. (023237884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Pharmaceutical Technology, Inc.023237884manufacture(57377-010) , pack(57377-010)