ADDEX-1000- naltrexone pellet, implantable

Addex-1000 by

Drug Labeling and Warnings

Addex-1000 by is a Prescription medication manufactured, distributed, or labeled by Advanced Pharmaceutical Technology, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ADDEX-1000 
naltrexone pellet, implantable

Product 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)