Addex-1000

Manufacturer: Advanced Pharmaceutical Technology, Inc.
Effective date: 2022-10-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:52:26

Label at a glance#

ProductAddex-1000

Active ingredientNALTREXONE

Label structure6 sections

Storage and handling

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

Label contents#

Full prescribing information#

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:

SPL UNCLASSIFIED SECTION

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-

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Addex-1000
Naltrexone
ETHYLCELLULOSES
POVIDONE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57377-010	57377-010-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
POVIDONE	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
NALTREXONE	5S6W795CQM	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2377ce76-2f70-a754-e063-6394a90a20e0			6c52a716-44fb-c0a7-e053-2991aa0a93f3	2024-10-02		Exact identifier spl set id: 6c52a716-44fb-c0a7-e053-2991aa0a93f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.