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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57377-010
Product Classification
G
Generic Name
Naltrexone
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 4, 2022
FDA Product Classification
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.