ADDEX-1000- naltrexone pellet, implantable 
Advanced Pharmaceutical Technology, Inc.

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Addex-1000

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.

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

Each pellet contains: 1 Gram Naltrexone.

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

Package Labeling:

Label

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)

Revised: 10/2022
Document Id: ea3f5929-0ee9-517b-e053-2995a90a1f33
Set id: 6c52a716-44fb-c0a7-e053-2991aa0a93f3
Version: 5
Effective Time: 20221004
 
Advanced Pharmaceutical Technology, Inc.