DEXTENZA
These highlights do not include all the information needed to use DEXTENZA safely and effectively. See full prescribing information for DEXTENZA. DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular useInitial U.S. Approval: 1958
Approved
Approval ID
7514e6b8-c33f-4fbf-8810-ef520e1eb4bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2021
Manufacturers
FDA
Ocular Therapeutix, Inc.
DUNS: 063391985
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dexamethasone
PRODUCT DETAILS
NDC Product Code70382-204
Application NumberNDA208742
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC, INTRACANALICULAR
Effective DateNovember 30, 2018
Generic Namedexamethasone
INGREDIENTS (6)
LYSYLLYSYLLYSINEInactive
Code: Y7F82M80K8
Classification: IACT
FLUORESCEINInactive
Code: TPY09G7XIR
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
dexamethasoneActive
Quantity: 0.4 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/18/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/18/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/18/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/18/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/18/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/18/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/18/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/18/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/18/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/18/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/18/2025