Ozurdex Implant
Product Images NDC 0023-3348

6 FDA label images from Allergan, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Ozurdex (NDC 0023-3348). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Allergan, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1: Mean Iop During The Study (Ozurdex 01)

Figure 1: Mean Iop During The Study (Ozurdex 01)
A line graph comparing mean intraocular pressure (mm Hg) over various months and visits between two groups: DEX 700 (N=384) and Sham (N=326). The x-axis shows the cycle months and visits, while the y-axis represents mean intraocular pressure values ranging from 0 to 25 mm Hg.*
FDA Label Image

The Structural Formula For Ozurdex® Is An Intravitreal Implant Containing 0.7 mg (700 Mcg) Dexamethasone In The Novadur® Solid Polymer Sustained-release Drug Delivery System. Ozurdex® Is Preloaded Into A Single-use, Dds® Applicator To Facilitate Injection Of The Rod-shaped Implant Directly Into The Vitreous. The Novadur® System Contains Poly (d,l-lactide-co-glycolide) Plga Intravitreal Polymer Matrix Without A Preservative. The Chemical Name For Dexamethasone Is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. (Ozurdex 02)

The Structural Formula For Ozurdex® Is An Intravitreal Implant Containing 0.7 mg (700 Mcg) Dexamethasone In The Novadur® Solid Polymer Sustained-release Drug Delivery System. Ozurdex® Is Preloaded Into A Single-use, Dds® Applicator To Facilitate Injection Of The Rod-shaped Implant Directly Into The Vitreous. The Novadur® System Contains Poly (d,l-lactide-co-glycolide) Plga Intravitreal Polymer Matrix Without A Preservative. The Chemical Name For Dexamethasone Is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. (Ozurdex 02)
Chemical structure of dexamethasone, the active ingredient in OZURDEX implant. The diagram shows the steroid backbone with labeled functional groups, hydroxyls, methyl groups, and fluorine atom.*
FDA Label Image

Figure 2: Proportion Of Subjects With ≥ 15 Letters Improvement From Baseline Bcva In The Study Eye (Ozurdex 03)

Figure 2: Proportion Of Subjects With ≥ 15 Letters Improvement From Baseline Bcva In The Study Eye (Ozurdex 03)
Four line graphs showing the proportion of subjects gaining 15 or more letters in visual acuity over time by study visit month, comparing Ozurdex and sham groups. The graphs separate results for phakic and pseudophakic subjects from two different studies, illustrating changes across monthly study visits up to 36 months.*
FDA Label Image

Figure 3: Mean Bcva Change From Baseline (Ozurdex 04)

Figure 3: Mean Bcva Change From Baseline (Ozurdex 04)
Four line graphs showing mean change from baseline in BCVA (Letter) over time in months for two studies comparing Ozurdex (dexamethasone intravitreal implant) versus sham treatment. The top two graphs represent Study 1 with phakic and pseudophakic subjects, and the bottom two graphs represent Study 2 with phakic and pseudophakic subjects. Each graph plots mean changes for Ozurdex and sham groups across multiple study visits up to 39 months.*
FDA Label Image

Shapedescription Automatically Generated (Ozurdex 05)

FDA Label Image

Ndc 0023-3348-07ozurdex®(dexamethasoneintravitreal Implant) 0.7 mgfor Intravitreal Injectionrx Onlycontents Includes:one Sterile, Single-use Applicatorrefer To Accompanying Prescribing Information For Additional Informationabbvie (Ozurdex 06)

Ndc 0023-3348-07ozurdex®(dexamethasoneintravitreal Implant) 0.7 mgfor Intravitreal Injectionrx Onlycontents Includes:one Sterile, Single-use Applicatorrefer To Accompanying Prescribing Information For Additional Informationabbvie (Ozurdex 06)
Packaging label for OZURDEX (dexamethasone) intravitreal implant 0.7 mg by Allergan, Inc., NDC 0023-3348-07. The implant is provided as one sterile, single-use applicator. The label highlights storage conditions and intravitreal injection use with Rx only designation, and includes step-by-step directions for use.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.