Label: ADDEX-1000- naltrexone pellet, implantable
- NDC Code(s): 57377-010-00
- Packager: Advanced Pharmaceutical Technology, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated October 4, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Caution:
- Do Not Use-
- STORAGE AND HANDLING
- COMPONENTS
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ADDEX-1000
naltrexone pellet, implantableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57377-010 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NALTREXONE (UNII: 5S6W795CQM) (NALTREXONE - UNII:5S6W795CQM) NALTREXONE 1000 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57377-010-00 1 in 1 AMPULE; Type 0: Not a Combination Product 05/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 05/16/2018 Labeler - Advanced Pharmaceutical Technology, Inc. (023237884) Establishment Name Address ID/FEI Business Operations Advanced Pharmaceutical Technology, Inc. 023237884 manufacture(57377-010) , pack(57377-010)