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Ozurdex dexamethasone .7 mg Implant, 1 implant — NDC 00023-3348-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ozurdex dexamethasone .7 mg Implant, 1 implant — NDC 0023-3348-07 (Billing 00023-3348-07)

by Allergan, Inc. · 1 POUCH in 1 CARTON / 1 IMPLANT in 1 POUCH

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 00023-3348-07
🏷️ FDA NDC (as labeled) 0023-3348-07 billing pads the labeler segment with a zero
This package
Contains1 implant Medicaid pays$1,278.53 / unit · 12 mo Per package$1,278.53 / 1 implant · Medicaid Pack sizes2 compare ↓
Main listing for product 0023-3348 · Also comes in: 1 implant 0023-3348-08
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

FDA NDC (as labeled) 0023-3348-07
Product NDC 0023-3348
11-digit billing NDC 00023334807
NCPDP billing unit EA — each (per item)
RxCUI 854177, 854181
UNII 7S5I7G3JQL
Application # NDA022315
SPL Set ID 4b204f44-6e8a-4d17-803c-268f0b04679f
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-01
Route INTRAVITREAL
Dosage form IMPLANT
Substance DEXAMETHASONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86300010002320
GPI class Ozurdex
GCN Seq No 065561
GCN 27558
HICL code 002889
Ingredient (HICL) Dexamethasone
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name OZURDEX 0.7 MG IMPLANT
FDB brand name Ozurdex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 0023-3348-07 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00023-3348-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OZURDEX 0.7 MG IMPLANT Ingredient Dexamethasone
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Dexamethasone guide →
8
Nutrient depletion considerations

Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0023-3348-07
11-digit billing NDC00023-3348-07
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7312
DescriptorInjection, dexamethasone, intravitreal implant, 0.1 mg
Billing units / pkg7 units
How the units are derivedThis package is 0.7; the HCPCS unit is 0.1 MG, so one package = 7 billing units.
Medicare Part B spend (2026 (Q1))$10,243,531 · 6,823 claims · $1,501.32 per claim (all NDCs under J7312)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
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?
This package contains 1 implant — 1 pouch in 1 carton / 1 implant in 1 pouch.
How does this package differ from NDC 00023-3348-08?
Both are Ozurdex dexamethasone .7 mg Implant — the drug itself is identical. This page's package is the 1 implant one, while NDC 00023-3348-08 is the 1 implant package.
What NDC number is used to bill for this package of Ozurdex dexamethasone .7 mg Implant?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ozurdex .7 mgthis 00023-3348-07 Allergan, 1 implant — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA022315 (NDA)
Labeler code00023
First marketedSep 2009
Product typeHuman Prescription Drug
Portfolio188 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 117 words ▾

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 min read ▾

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 38 words ▾

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 157 words ▾

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 166 words ▾

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 ~3 min read ▾

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 ~2 min read ▾

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 220 words ▾

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 15 words ▾

8.4Pediatric Use Safety and effectiveness of OZURDEX in pediatric patients have not been established.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 189 words ▾

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 31 words ▾

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 41 words ▾

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 ~1 min read ▾

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 199 words ▾

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 155 words ▾

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 ~3 min read ▾

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 37 words ▾

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 34 words ▾

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 8 words ▾

Dosage and Administration, Administration ( 2.2 ) 2/2026

📄 Package Label / Principal Display Panel 60 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.6K
Units reimbursed last 4 qtrs
6.1K
Gross reimbursed last 4 qtrs
$7.77M
Avg / prescription
$1,378.01
Avg / unit
$1,278.60
Latest quarter Q1 2026
1KRx
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 2,547 Rx Managed care · 3,095 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 206 units · 2.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 26 units · 0.5 per 100k residents MN Wisconsin: no data reported WI Michigan: 211 units · 2.1 per 100k residents MI New York: 719 units · 3.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 103 units · 2.4 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 348 units · 2.8 per 100k residents IL Indiana: 100 units · 1.5 per 100k residents IN Ohio: 318 units · 2.7 per 100k residents OH Pennsylvania: 274 units · 2.1 per 100k residents PA New Jersey: 170 units · 1.8 per 100k residents NJ Massachusetts: 118 units · 1.7 per 100k residents MA California: 623 units · 1.6 per 100k residents CA Utah: 11 units · 0.3 per 100k residents UT Colorado: 149 units · 2.5 per 100k residents CO Nebraska: no data reported NE Missouri: 154 units · 2.5 per 100k residents MO Kentucky: 93 units · 2.1 per 100k residents KY West Virginia: no data reported WV Virginia: 265 units · 3.0 per 100k residents VA Maryland: 261 units · 4.2 per 100k residents MD Connecticut: 283 units · 7.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 281 units · 3.8 per 100k residents AZ New Mexico: 166 units · 7.9 per 100k residents NM Kansas: no data reported KS Arkansas: 11 units · 0.4 per 100k residents AR Tennessee: 17 units · 0.2 per 100k residents TN North Carolina: 332 units · 3.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 9 units · 0.2 per 100k residents OK Louisiana: no data reported LA Mississippi: 60 units · 2.0 per 100k residents MS Alabama: 67 units · 1.3 per 100k residents AL Georgia: 178 units · 1.6 per 100k residents GA D.C.: 33 units · 4.9 per 100k residents DC Hawaii: no data reported HI Texas: 167 units · 0.5 per 100k residents TX Florida: 224 units · 1.0 per 100k residents FL
Units reimbursed · per 100k residents
0.27.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 7.9 /100k
2 Connecticut 7.8 /100k
3 D.C. 4.9 /100k
4 Maryland 4.2 /100k
5 Arizona 3.8 /100k
6 New York 3.7 /100k
7 North Carolina 3.1 /100k
8 Virginia 3.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 implant this page00023-3348-07 5,642 Rx · $7,774,725
1 implant00023-3348-08 No Medicaid data
Drug total (last 4 qtrs): 5,642 Rx · 6,081 units · $7,774,725 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ozurdex — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ozurdex. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$311.3K
Claims incl. refills
179
Beneficiaries
172
Spend / beneficiary
$1,809.84
Spend / claim
$1,739.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OZURDEX (this brand).

Top reported reactions

Fatigue17,227
Diarrhoea17,047
Plasma Cell Myeloma14,163
Nausea13,971
Pneumonia13,669
Death13,393
Neutropenia11,600

Reporter sex

293,847 reports
Male · 51%
Female · 48%
Unknown · 1%

Serious outcomes

Death47,680
Disabling5,948
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 29,150 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Allergan, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 implant (00023-3348-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allergan, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7312 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.