Ozurdex dexamethasone .7 mg Implant, 1 implant — NDC 0023-3348-07 (Billing 00023-3348-07)
This is a package of 1 implant of Ozurdex dexamethasone .7 mg Implant from Allergan, Inc., marketed since Sep 2009 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0023-3348-07 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0023 labeler · 3348 product · 07 package
- Package marketed since
- Sep 1, 2009
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 1 EA per package
- Barcode (UPC-A, from the NDC)
- 3 0023334807 9
- Medicaid fills, this package
- 5,642 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 065561
- GCN: 27558
- GPI-14 (Medi-Span): 86300010002320
- HICL (First Databank): 002889
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 854177
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's a steroid that calms inflammation and immune overreaction. Depending on the product, it treats allergic conditions, skin diseases, hormone disorders and eye conditions. Hemady...
- Follow your prescription label exactly. Tablets and liquid are swallowed, and your prescriber sets the amount based on your condition. Please don't stop suddenly after long use, be...
- Increased appetite, weight gain, trouble sleeping, mood swings, nausea and fluid retention are common. Call your doctor for signs of infection, black stools, vision changes, or sev...
- Some medicines interact with it, including certain antifungals, blood thinners, diabetes medicines, aspirin or NSAIDs, and estrogen products. Check with me before adding anything n...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dexamethasone — tap one for details:
Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1,278.53 | $1,278.53 / 1 implant |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7312 | $203.656 / J7312 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00023-3348-07 You're viewing this Main listing | 1 POUCH in 1 CARTON / 1 IMPLANT in 1 POUCH | 2009-09-01 | — | Active |
| 00023-3348-08 0023-3348-08 | 1 POUCH in 1 CARTON / 1 IMPLANT in 1 POUCH Sample | 2009-09-01 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00023-3348-08?
What NDC number is used to bill for this package of Ozurdex dexamethasone .7 mg Implant?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ozurdex .7 mgthis 00023-3348-07 | Allergan, | 1 implant | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII WE369X5600
A synthetic plastic polymer made from two natural compounds, lactic acid and glycolic acid, blended equally and designed to break down in the body over time. Used as a coating or matrix to control how slowly a medicine is released into the bloodstream.
-
UNII 7SVE964630
A synthetic plastic polymer made from lactic acid and glycolic acid that breaks down gradually in the body. It's used to control how quickly the medicine is released, forming a matrix or coating that dissolves over time.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Allergan, Inc. labeler code 00023
- BOTOX onabotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution NDC 0023-1145-01
- SkinMedica Acne Clarifying Treatment Salicylic Acid 20 mg/mL Lotion NDC 0023-1230-01
- Acular Ketorolac Tromethamine 5 mg/mL Solution/ Drops NDC 0023-2181-05
- REFRESH TEARS PF carboxymethylcellulose sodium, Glycerin 5 mg/mL; 9 mg/mL Solution/ Drops NDC 0023-3110-10
- LUMIGAN bimatoprost .1 mg/mL Solution/ Drops NDC 0023-3205-02
- REFRESH OPTIVE carboxymethylcellulose sodium and glycerin 5 mg/mL; 9 mg/mL Solution/ Drops NDC 0023-3240-01
- Refresh Optive Carboxymethylcellulose Sodium, Glycerin 5 mg/mL; 9 mg/mL Solution/ Drops NDC 0023-3416-05
- ACUVAIL ketorolac tromethamine 4.5 mg/mL Solution/ Drops NDC 0023-3507-05
- ZYMAXID gatifloxacin 5 mg/mL Solution/ Drops NDC 0023-3615-01
- LATISSE bimatoprost .3 mg/mL Solution/ Drops NDC 0023-3616-05
- ACZONE dapsone 50 mg/g Gel NDC 0023-3670-03
- Refresh Relieva PF Xtra Carboxymethylcellulose Sodium and Glycerin 5 mg/mL; 9 mg/mL Solution/ Drops NDC 0023-3782-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) ( 1.1 ) The treatment of non-infectious uveitis affecting the posterior segment of the eye ( 1.2 ) The treatment of diabetic macular edema ( 1.3 )
1.1Retinal Vein Occlusion OZURDEX ® (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
1.2Posterior Segment Uveitis OZURDEX is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
1.3Diabetic Macular Edema OZURDEX is indicated for the treatment of diabetic macular edema.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For ophthalmic intravitreal injection. ( 2.1 ) The intravitreal injection procedure should be carried out under controlled aseptic conditions. ( 2.2 ) Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. ( 2.2 )
2.1General Dosing Information For ophthalmic intravitreal injection.
2.2Administration The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide applied to the periocular skin, eyelid and ocular surface are recommended to be given prior to the injection. Remove the foil pouch from the carton and examine for damage.
Then, open the foil pouch over a sterile field and gently drop the applicator on a sterile tray. Perform a detailed visual inspection of the applicator, including ensuring that the actuator button has not been depressed, and the safety tab is in place. Carefully remove the plastic safety cap taking care to avoid contacting the needle tip.
Inspect the needle tip for damage prior to use; the implant retention plug may be visible in the bevel and should not be removed. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab.
The long axis of the applicator should be held parallel to the limbus, and the sclera should be engaged at an oblique angle with the bevel of the needle up (away from the sclera) to create a shelved scleral path. The tip of the needle is advanced within the sclera for about 1 mm (parallel to the limbus), then re-directed toward the center of the eye and advanced until penetration of the sclera is completed and the vitreous cavity is entered. The needle should not be advanced past the point where the sleeve touches the conjunctiva.
Slowly depress the actuator button until an audible and/or palpable click is noted. Before withdrawing the applicator from the eye, make sure that the actuator button is fully depressed and has locked flush with the applicator surface. Remove the needle in the same direction as used to enter the vitreous.
Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
Each applicator can only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new applicator must be used, and the sterile field, syringe, gloves, drapes, and eyelid speculum should be changed before OZURDEX is administered to the other eye.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR ® solid polymer drug delivery system. Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR ® solid polymer drug delivery system. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Glaucoma ( 4.2 ) Torn or ruptured posterior lens capsule ( 4.3 ) Hypersensitivity ( 4.4 )
4.1Ocular or Periocular Infections OZURDEX (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
4.2Glaucoma OZURDEX is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
4.3Torn or Ruptured Posterior Lens Capsule OZURDEX is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX use. 4. 4 Hypersensitivity OZURDEX is contraindicated in patients with known hypersensitivity to any components of this product [see Adverse Reactions ( 6 )] .
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. ( 5.1 ) Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. ( 5.2 )
5.1Intravitreal Injection-related Effects Intravitreal injections, including those with OZURDEX, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection [see Patient Counseling Information ( 17 )] .
5.2Steroid-related Effects Use of corticosteroids including OZURDEX may produce posterior subcapsular cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses [see Adverse Reactions ( 6.1 )] . Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In controlled studies, the most common adverse reactions reported by 20–70% of patients were cataract, increased intraocular pressure and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Figure 1: Mean IOP during the study
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids including OZURDEX include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Retinal Vein Occlusion and Posterior Segment Uveitis The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis): Table 1: Adverse Reactions Reported by Greater than 2% of Patients MedDRA Term OZURDEX N=497 (%) Sham N=498 (%) Intraocular pressure increased 125 (25%) 10 (2%) Conjunctival hemorrhage 108 (22%) 79 (16%) Eye pain 40 (8%) 26 (5%) Conjunctival hyperemia 33 (7%) 27 (5%) Ocular hypertension 23 (5%) 3 (1%) Cataract 24 (5%) 10 (2%) Vitreous detachment 12 (2%) 8 (2%) Headache 19 (4%) 12 (2%) Increased IOP with OZURDEX peaked at approximately week 8.
During the initial treatment period, 1% (3/421) of the patients who received OZURDEX required surgical procedures for management of elevated IOP. Following a second injection of OZURDEX in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year. In a 2 year observational study, among patients who received >2 injections, the most frequent adverse reaction was cataract 54% (n= 96 out of 178 phakic eyes at baseline).
Other frequent adverse reactions from the 283 treated eyes, regardless of lens status at baseline, were increased IOP 24% (n = 68) and vitreous hemorrhage 6.0% (n = 17). Diabetic Macular Edema The following information is based on the combined clinical trial results from 2 randomized, 3-year, sham-controlled studies in patients with diabetic macular edema. Discontinuation rates due to the adverse reactions listed in Table 2 were 3% in the OZURDEX group and 1% in the Sham group.
The most common ocular (study eye) and non-ocular adverse reactions are shown in Tables 2 and 3: Table 2: Ocular Adverse Reactions Reported by ≥ 1% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of Patients MedDRA Term OZURDEX N=324 (%) Sham N=328 (%) Ocular Cataract 1 166/243 2 (68%) 49/230 (21%) Conjunctival hemorrhage 73 (23%) 44 (13%) Visual acuity reduced 28 (9%) 13 (4%) Conjunctivitis 19 (6%) 8 (2%) Vitreous floaters 16 (5%) 6 (2%) Conjunctival edema 15 (5%) 4 (1%) Dry eye 15 (5%) 7 (2%) Vitreous detachment 14 (4%) 8 (2%) Vitreous opacities 11 (3%) 3 (1%) Retinal aneurysm 10 (3%) 5 (2%) Foreign body sensation 7 (2%) 4 (1%) Corneal erosion 7 (2%) 3 (1%) Keratitis 6 (2%) 3 (1%) Anterior Chamber Inflammation 6 (2%) 0 (0%) Retinal tear 5 (2%) 2 (1%) Eyelid ptosis 5 (2%) 2 (1%) Non-ocular Hypertension 41 (13%) 21 (6%) Bronchitis 15 (5%) 8 (2%) 1 Includes cataract, cataract nuclear, cataract subcapsular, lenticular opacities in patients who were phakic at baseline.
Among these patients, 61% of OZURDEX subjects vs. 8% of sham-controlled subjects underwent cataract surgery. 2 243 of the 324 OZURDEX subjects were phakic at baseline; 230 of 328 sham-controlled subjects were phakic at baseline.
Increased Intraocular Pressure Table 3: Summary of Elevated Intraocular Pressure (IOP) Related A… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with OZURDEX in pregnant women. Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of the abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than the recommended human ophthalmic dose (RHOD) of OZURDEX (0.7 milligrams dexamethasone), respectively. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. A dose of 0.75 mg/kg/day in the mouse is approximately 5 times an OZURDEX injection in humans (0.7 mg dexamethasone) on a mg/m 2 basis. In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.20 mg/kg/day, on gestational day 6 followed by 0.13 mg/kg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys.
A dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an OZURDEX injection in humans (0.7 mg dexamethasone) on a mg/m 2 basis. A no-observed-adverse-effect-level (NOAEL) was not identified in the mouse or rabbits studies. 8.
2 Lactation Risk Summary Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production or cause other unwanted effects. There is no information regarding the presence of dexamethasone in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of OZURDEX to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for OZURDEX and any potential adverse effects on the breastfed child from OZURDEX.
8.4Pediatric Use Safety and effectiveness of OZURDEX in pediatric patients have not been established.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with OZURDEX in pregnant women. Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of the abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than the recommended human ophthalmic dose (RHOD) of OZURDEX (0.7 milligrams dexamethasone), respectively. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. A dose of 0.75 mg/kg/day in the mouse is approximately 5 times an OZURDEX injection in humans (0.7 mg dexamethasone) on a mg/m 2 basis. In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.20 mg/kg/day, on gestational day 6 followed by 0.13 mg/kg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys.
A dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an OZURDEX injection in humans (0.7 mg dexamethasone) on a mg/m 2 basis. A no-observed-adverse-effect-level (NOAEL) was not identified in the mouse or rabbits studies.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of OZURDEX in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
12.3Pharmacokinetics Plasma concentrations were obtained from 21 patients with macular edema due to branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and 21 patients with diabetic macular edema (DME) prior to dosing and at 4 to 5 additional post-dose timepoints on Days 1, 7, 21, 30, 45, 60, and 90 following the administration of the first intravitreal implant containing 0.7 mg dexamethasone. In RVO and DME patients, the majority of plasma dexamethasone concentrations were below the lower limit of quantitation (LLOQ = 50 pg/mL).
Plasma dexamethasone concentrations from 12% of samples were above the LLOQ, ranging from 52 pg/mL to 102 pg/mL. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients. In an in vitro metabolism study, following the incubation of [ 14 C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING OZURDEX (dexamethasone intravitreal implant) 0.7 mg is supplied in a foil pouch with 1 single-use plastic applicator, NDC 0023-3348-07. Storage: Store at 15 o C to 30 o C (59 o F to 86 o F).
📋 Description ▾
11 DESCRIPTION OZURDEX is a sterile intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR solid polymer sustained-release drug delivery system which does not contain an antimicrobial preservative. OZURDEX is preloaded into a single-use, DDS applicator to facilitate injection of the rodshaped implant directly into the vitreous. The NOVADUR system contains two poly D,L-lactide-co-glycolide (PLGA) polymer excipients.
Both of these polymer materials have the same PLGA backbone, but the terminal end groups differ between them. One polymer, DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester, is ester terminated, and the other DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid is acid terminated. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β, 16α)-.
Its structural formula is: MW 392.47; molecular formula: C 22 H 29 FO 5 Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol. The PLGA matrix slowly degrades to lactic acid and glycolic acid. 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)-.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Steroid-related Effects Advise patients that a cataract may occur after repeated treatment with OZURDEX. If this occurs, advise patients that their vision will decrease, and they will need an operation to remove the cataract and restore their vision. Advise patients that they may develop increased intraocular pressure with OZURDEX treatment, and the increased IOP will need to be managed with eye drops, and, rarely, with surgery.
Intravitreal Injection-related Effects Advise patients that in the days following intravitreal injection of OZURDEX, patients are at risk for potential complications including in particular, but not limited to, the development of endophthalmitis or elevated intraocular pressure. When to Seek Physician Advice Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist. Driving and Using Machines Inform patients that they may experience temporary visual blurring after receiving an intravitreal injection.
Advise patients not to drive or use machines until this has been resolved. Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2026 AbbVie.
All rights reserved. OZURDEX and its design are trademarks of Allergan, Inc., an AbbVie company. 20095708 Shape Description automatically generated
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Plasma concentrations were obtained from 21 patients with macular edema due to branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and 21 patients with diabetic macular edema (DME) prior to dosing and at 4 to 5 additional post-dose timepoints on Days 1, 7, 21, 30, 45, 60, and 90 following the administration of the first intravitreal implant containing 0.7 mg dexamethasone. In RVO and DME patients, the majority of plasma dexamethasone concentrations were below the lower limit of quantitation (LLOQ = 50 pg/mL).
Plasma dexamethasone concentrations from 12% of samples were above the LLOQ, ranging from 52 pg/mL to 102 pg/mL. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients. In an in vitro metabolism study, following the incubation of [ 14 C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Retinal Vein Occlusion The efficacy of OZURDEX for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) was assessed in two, multicenter, double-masked, randomized, parallel studies. Following a single injection, OZURDEX demonstrated the following clinical results for the percent of patients with ≥ 15 letters of improvement from baseline in best-corrected visual acuity (BCVA): Table 4: Number (Percent) of Patients with ≥ 15 Letters Improvement from Baseline in BCVA Study Day Study 1 Study 2 OZURDEX N=201 Sham N=202 p-value* OZURDEX N=226 Sham N=224 p-value* Day 30 40 (20%) 15 (7%) < 0.01 51 (23%) 17 (8%) <
0.01Day 60 58 (29%) 21 (10%) < 0.01 67 (30%) 27 (12%) <
0.01Day 90 45 (22%) 25 (12%) < 0.01 48 (21%) 31 (14%) 0.039 Day 180 39 (19%) 37 (18%) 0.780 53 (24%) 38 (17%) 0.087 *P-values were based on the Pearson’s chi-square test. In each individual study and in a pooled analysis, time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response rate curves were significantly faster with OZURDEX compared to sham (p < 0.01), with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than sham-treated patients. The onset of a ≥ 15 letter (3-line) improvement in BCVA with OZURDEX occurs within the first two months after implantation in approximately 20-30% of subjects.
The duration of effect persists approximately one to three months after onset of this effect. Posterior Segment Uveitis The efficacy of OZURDEX was assessed in a single, multicenter, masked, randomized study of 153 patients with non-infectious uveitis affecting the posterior segment of the eye. After a single injection, the percent of patients reaching a vitreous haze score of 0 (where a score of 0 represents no inflammation) was statistically significantly greater for patients receiving OZURDEX versus sham at week 8 (primary time point) (47% versus 12%).
The percent of patients achieving a 3-line improvement from baseline BCVA was 43% for patients receiving OZURDEX versus 7% for sham at week 8. Diabetic Macular Edema The efficacy of OZURDEX for the treatment of diabetic macular edema was assessed in two, multicenter, masked, randomized, sham-controlled studies. Subjects were to be evaluated for retreatment eligibility every three months starting from Month 6 but could only receive successive treatments at least 6 months apart.
Retreatment was based on physician’s discretion after examination including Optical Coherence Tomography. Patients in the OZURDEX arm received an average of 4 treatments during the 36 months. The primary endpoint was the proportion of patients with 15 or more letters improvement in BCVA from baseline at Month 39 or final visit for subjects who exited the study at or prior to Month 36.
The Month 39 extension was included to accommodate the evaluation of safety and efficacy outcomes for subjects who received re-treatment at Month 36. Only fourteen percent of the study patients completed the Month 39 visit (16.8% from OZURDEX and 12.2% from Sham). Table 5: Visual Acuity outcomes at Month 39 (All randomized subjects with LOCF c ) Study Outcomes O ZURDEX Sham Estimated Difference (95% CI) 1 a Mean (SD) Baseline BCVA (Letters) 56 (10) 57 (9) Median (range) Baseline BCVA (Letters) 59 (34-95) 58 (34-74) Gain of ≥15 letters in BCVA (n(%)) 34 (21%) 19 (12%) 9.3% (1.4%, 17.3%) Loss of ≥15 letters in BCVA (n(%)) 15 (9%) 17 (10%) -1.1% (-7.5%, 5.3%) Mean change in BCVA (SD) 4.1 (13.9) 0.9 (11.9) 3.2 (0.4, 5.9) 2 b Mean (SD) Baseline BCVA (Letters) 55 (10) 56 (9) Median (range) Baseline BCVA (Letters) 58 (34-72) 58 (36-82) Gain of ≥15 letters in BCVA (n(%)) 30 (18%) 16 (10%) 8.4% (0.9%, 15.8%) Loss of ≥15 letters in BCVA (n(%)) 30 (18%) 18 (11%) 7.1% (-0.5%, 14.7%) Mean change in BCVA (SD) 0.4 (17.5) 0.8 (13.6) -0.7 (-4.1, 2.6) a Study 1: OZURDEX, N=163; Sham, N=165 b Study 2: OZURDEX, N=165; Sham, N=163 c 14% (16.8% from OZURDEX and 12.2% f… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to determine whether OZURDEX (dexamethasone intravitreal implant) has the potential for carcinogenesis or mutagenesis. Fertility studies have not been conducted in animals.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to determine whether OZURDEX (dexamethasone intravitreal implant) has the potential for carcinogenesis or mutagenesis. Fertility studies have not been conducted in animals.
📄 Recent Major Changes ▾
Dosage and Administration, Administration ( 2.2 ) 2/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0023-3348-07 Ozurdex ® (dexamethasone intravitreal implant) 0.7 mg For Intravitreal Injection Rx only Contents includes: One Sterile, Single-Use Applicator Refer to accompanying prescribing information for additional information abbvie NDC 0023-3348-07 Ozurdex® (dexamethasone intravitreal implant) 0.7 mg For Intravitreal Injection Rx only Contents includes: One Sterile, Single-Use Applicator Refer to accompanying prescribing information for additional information abbvie
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |