Addex-1000
Addex-1000
Approved
Approval ID
6c52a716-44fb-c0a7-e053-2991aa0a93f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
Advanced Pharmaceutical Technology, Inc.
DUNS: 023237884
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naltrexone
PRODUCT DETAILS
NDC Product Code57377-010
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 4, 2022
Generic NameNaltrexone
INGREDIENTS (4)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
NALTREXONEActive
Quantity: 1000 mg in 1 1
Code: 5S6W795CQM
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/27/2018
Package Labeling:
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/27/2018
Do Not Use-
if pouch is damaged or open since it will no longer be sterile.
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 12/27/2018
STORE IN A COOL DRY PLACE. (TEMPERATURE NOT TO EXCEED 30 OC)
COMPONENTS
LOINC: 60559-2Updated: 12/27/2018
Each pellet contains: 1 Gram Naltrexone.
Plus Inactives: ethyl cellulose USP, polyvinyl pyrrolidone USP, stearic acid USP.