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Dexycu dexamethasone 517 ug/.005mL Injection, Suspension, 1 vial — NDC 71879-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dexycu dexamethasone 517 ug/.005mL Injection, Suspension, 1 vial — NDC 71879-001-01 (Billing 71879-0001-01)

by EyePoint Pharmaceuticals US, Inc · 1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS

This is a package of 1 vial of Dexycu dexamethasone 517 ug/.005mL Injection, Suspension from EyePoint Pharmaceuticals US, Inc, no longer marketed (first marketed May 2018), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 71879-0001-01
🏷️ FDA NDC (as labeled) 71879-001-01 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71879-001-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71879 labeler · 001 product · 01 package
Package marketed since
May 22, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7187900101 7
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71879-001-01
Product NDC 71879-001
11-digit billing NDC 71879000101
NCPDP billing unit ML — per mL (volume)
RxCUI 2045404, 2045409
UNII 7S5I7G3JQL
Application # NDA208912
SPL Set ID 583d70ed-bc42-465b-983d-c770db58406f
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2018-05-22
Route INTRAOCULAR
Dosage form INJECTION, SUSPENSION
Substance DEXAMETHASONE

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

GPI-14 86300010001860
GPI class Dexycu
GCN Seq No 078417
GCN 44741
HICL code 044921
Ingredient (HICL) Dexamethasone/Pf
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 DEXYCU 9% VIAL
FDB brand name Dexycu
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078417
  • GCN: 44741
  • GPI-14 (Medi-Span): 86300010001860
  • HICL (First Databank): 044921
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 2045404
Why two NDCs? The FDA registers this code as 71879-001-01 — a 5-3-2 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 product segment → 71879-0001-01. 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 DEXYCU 9% VIAL Ingredient Dexamethasone/Pf
📖 What it is MedlinePlus · NLM

Dexamethasone injection is used to treat severe allergic reactions. It is used in the management of certain types of edema (fluid retention and swelling; excess fluid held in body tissues,) gastrointestinal disease, and certain types of arthritis. Dexamethasone injection is also used for diagnostic testing. Dexamethasone injection is also used to treat certain conditions that affect the blood, skin, eyes, thyroid, kidneys, lungs, and nervous system. It is sometimes used in combination with other medications to treat symptoms of low corticosteroid levels (lack of certain substances that are usu...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation and treats many conditions, including severe allergic reactions, arthritis flares, certain skin diseases, brain swelling, and adrenal problems. It can also be...
  • A healthcare professional gives it into a vein, muscle, joint, or lesion, depending on why you need it. Your dose is tailored to you and is usually brought down to the lowest effec...
  • If you have been treated for more than a few days, it is usually stopped gradually. Stopping too fast can cause low adrenal function that may last for months. Never change the plan...
  • Call right away for signs of infection, a severe allergic reaction, vision changes, or eye pain. Steroids can hide infection, so even mild symptoms matter. Seek urgent help for sud...
📖 Read our full Dexamethasone Injection 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.

🧪 Full Dexamethasone nutrient depletion report →
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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71879-0001-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS 2018-05-22 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexycu 517 ug/.005mLthis 71879-0001-01 EyePoint 1 vial — — Discontinued —
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

🏛️
2018
First FDA approval
Feb 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 9, 2018 RLD RS ⏳ ~12.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10028965 — method of use (U-2340)
US 11097061 — method of use (U-3418)
US 10022502 — method of use (U-2340)
US 10799642 — drug product
US 10159683 — drug product
2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)
PatentTypeUse codeExpires
US 10028965 ↗ Method of use U-2340 May 23, 2034
US 11097061 ↗ Method of use U-3418 Jun 23, 2039
US 10022502 ↗ Method of use U-2340 Jun 22, 2034
US 10799642 ↗ Drug product — May 11, 2032
US 10159683 ↗ Drug product — May 23, 2034
Common questions
Is there a generic version of DEXYCU 9% VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DEXYCU 9% VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🧪 Avoiding an ingredient? See Dexamethasone Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 5233 ug / 0.005 mL UNII 5WBR36T90E
    A plasticizer derived from citric acid, used to make tablet coatings and film coatings more flexible and less brittle so they don't crack during handling and storage.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.

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

LabelerEyePoint Pharmaceuticals US, Inc
Application holderEYEPOINT PHARMACEUTICALS INC
FDA applicationNDA208912 (NDA)
Labeler code71879
First marketedMay 2018
Product typeHuman Prescription Drug
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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

1 INDICATIONS AND USAGE DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. DEXYCU is a corticosteroid indicated for the treatment of postoperative inflammation ( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intraocular administration ( 2 ). Administer 0.005 mL of DEXYCU into the posterior chamber inferiorly behind the iris at the end of ocular surgery ( 2 ).

2.1Dosing Information DEXYCU should be administered as a single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms).

2.2Preparation and Administration Each kit of DEXYCU is for a single administration. After preparation, 0.005 mL will be administered. The DEXYCU administration kit contains the following items: One glass vial: 0.5 mL of DEXYCU One sterile 1-mL syringe One sterile syringe guide One sterile syringe ring One sterile 18-gauge needle (1½ inches long), plastic cap attached One sterile 25-gauge bent cannula (8 mm long), plastic cap attached Step 1.

Prepare a sterile field. Remove the components of the administration kit from their respective pouches: syringe syringe guide syringe ring needle cannula Place onto the sterile field. Step 2.

Withdraw the syringe plunger approximately 1 inch. Place the syringe ring on the plunger (slit facing the plunger). Apply slight downward pressure until the syringe ring "snaps" into place.

Step 3. Place the 18-gauge needle firmly on the syringe. Remove the cap from the needle.

Depress the plunger completely and then withdraw the plunger to fill the syringe with air. Step 4. Mix using a vortex mixer or vigorously shake the vial of DEXYCU sideways for a minimum of 30 seconds.

The suspended drug material must be used immediately after shaking. Step 5. Remove the blue plastic flip-cap from the vial and wipe the top of rubber stopper with an alcohol pad.

Invert the vial. Step 6. Insert the needle into the vial and inject the air into the vial.

Making sure the needle tip is immersed in the drug material pooled in the neck of the inverted vial, fill the syringe by slowly withdrawing the plunger approximately 0.2 mL. Remove the needle from the vial and discard the unused portion in the vial. Step 7.

Remove the needle from the syringe. Firmly place the cannula on the syringe and remove the plastic cap. Hold the syringe vertically with the cannula pointing up.

Depress the plunger to expel air bubbles from syringe. Step 8. Affix the syringe guide over the syringe ring on the plunger.

Step 9. Depress the plunger until the syringe guide/ring mechanism comes gently into contact with the flange of the syringe. Lightly tap/flick the barrel of the syringe to remove any excess drug from the tip of the cannula.

Do not wipe or touch the tip of the cannula to remove excess drug. Step 10. Remove the syringe guide, leaving the syringe ring in place.

Caution to not move the plunger. The space between the syringe ring and the top of the plunger is the medication injection volume that will be applied to the patient's eye. The syringe is now ready for injection.

Step 11. In a single slow motion, inject 0.005 mL of the drug material behind the iris in the inferior portion of the posterior chamber. If the sphere of administered drug after intraocular injection appears to be larger than 2 mm in diameter, excess drug material may be removed by irrigation and aspiration in the sterile surgical setting PLEASE NOTE: Some drug material will remain in the syringe after the injection—this is necessary for accurate dosing.

Discard unused portion remaining in the syringe after administration. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone). Intraocular suspension: 9% equivalent to dexamethasone 103.4 mg/mL in a single-dose vial provided in a kit ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 ).

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Increase in Intraocular Pressure (IOP) : Monitor for increases in IOP ( 5.1 ). Delayed Healing : Monitor for delayed healing ( 5.2 ). Infection Exacerbation : Monitor and treat for any exacerbations of bacterial, viral or fungal infections ( 5.3 ). Cataract Progression : Cataracts may develop or progress in phakic patients ( 5.4 ).

5.1Increase in Intraocular Pressure Prolonged use of corticosteroids including DEXYCU may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma.

5.2Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids.

5.3Exacerbation of Infection The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection.

5.4Cataract Progression The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts.

🤒 Adverse Reactions 219 words ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Increase in Intraocular Pressure [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Infection Exacerbation [see Warnings and Precautions (5.3) ] Cataract Progression [see Warnings and Precautions (5.4) ] In controlled studies, the most common adverse reactions reported by 5-15% of patients were intraocular pressure increased, corneal edema and iritis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact EyePoint Pharmaceuticals US at 1-833-EYEPOINT (1-833-393-7646) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 trials of another drug and may not reflect the rates observed in practice. The following adverse events rates are derived from three clinical trials in which 339 patients received the 517 microgram dose of DEXYCU. The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis.

Other ocular adverse reactions occurring in 1-5% of subjects included, corneal endothelial cell loss, blepharitis, eye pain, cystoid macular edema, dry eye, ocular inflammation, posterior capsule opacification, blurred vision, reduced visual acuity, vitreous floaters, foreign body sensation, photophobia, and vitreous detachment.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of DEXYCU (dexamethasone intraocular suspension) 9% 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 abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose (RHOD) of DEXYCU (517 micrograms dexamethasone), respectively [see Data ] .

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 7-times the injected RHOD of DEXYCU, 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 5-times the injected RHOD of DEXYCU, on a mg/m 2 basis. A no-observed-adverse-effect-level (NOAEL) was not identified in the mouse or rabbit studies.

8.2Lactation Risk Summary Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. There is no information regarding the presence of injected DEXYCU in human milk, the effects on breastfed infants, or the effects on milk production to inform risk of DEXYCU to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for DEXYCU and any potential adverse effects on the breastfed child from DEXYCU.

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

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

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of DEXYCU (dexamethasone intraocular suspension) 9% 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 abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose (RHOD) of DEXYCU (517 micrograms dexamethasone), respectively [see Data ] .

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 7-times the injected RHOD of DEXYCU, 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 5-times the injected RHOD of DEXYCU, on a mg/m 2 basis. A no-observed-adverse-effect-level (NOAEL) was not identified in the mouse or rabbit studies.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of DEXYCU 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 older and younger patients.

🧬 Clinical Pharmacology 197 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dexamethasone is a corticosteroid. Corticosteroids have 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 Systemic exposure to dexamethasone was evaluated in a subgroup of patients enrolled in two studies (n=25 for the first study and n=13 for the second study). The patients received a single intraocular injection of DEXYCU containing 342 mcg or 517 mcg of dexamethasone at the end of cataract surgery and blood samples were collected prior to surgery and at several time points post-surgery between Day 1 and up to Day 30. In the first study, the dexamethasone plasma concentrations on post-surgery Day 1 ranged from 0.09 to 0.86 ng/mL and from 0.07 to 1.16 ng/mL following administration of DEXYCU 342 mcg and 517 mcg, respectively.

In the second study, dexamethasone plasma concentrations on post-surgery Day 1 ranged from 0.349 to 2.79 ng/mL following administration of DEXYCU 517 mcg. In both the studies, dexamethasone plasma concentrations declined over time and very few patients had quantifiable dexamethasone plasma concentrations at the final time point of sampling (Day 15 or Day 30).

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action Dexamethasone is a corticosteroid. Corticosteroids have 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 110 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each kit of DEXYCU contains a single dose for a single patient. The 2-mL glass vial is filled with 0.5 mL of 9% dexamethasone intraocular suspension and has a blue cap (NDC # 71879-001-01). Each kit also contains one sterile 18-gauge, 1.5-inch needle with a plastic cap attached, one sterile plastic 1-mL syringe for withdrawal of the vial contents, one sterile 25-gauge 8-mm cannula with a plastic cap attached for the intraocular administration, and one syringe assembly pouch containing a sterile ring and a sterile syringe guide used for measuring and injection of the 0.005 mL dose.

Store at 20°C to 25°C (68°F to 77°F).

📦 Storage and Handling 8 words ▾

Store at 20°C to 25°C (68°F to 77°F).

📋 Description 87 words ▾

11 DESCRIPTION DEXYCU (dexamethasone intraocular suspension) 9% is a corticosteroid, sterile, white to off-white opaque suspension for intraocular administration. Each vial of DEXYCU contains 0.5 mL of 9% w/w dexamethasone suspension equivalent to 51.7 mg of dexamethasone. The inactive ingredient is acetyl triethyl citrate.

DEXYCU does not contain an antimicrobial preservative. The chemical name of dexamethasone is pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. It has a molecular formula of C 22 H 29 FO 5 and a molecular weight of 392.46 grams per mole.

Its structural formula is: Chemical Structure

🧬 Pharmacokinetics 161 words ▾

12.3Pharmacokinetics Systemic exposure to dexamethasone was evaluated in a subgroup of patients enrolled in two studies (n=25 for the first study and n=13 for the second study). The patients received a single intraocular injection of DEXYCU containing 342 mcg or 517 mcg of dexamethasone at the end of cataract surgery and blood samples were collected prior to surgery and at several time points post-surgery between Day 1 and up to Day 30. In the first study, the dexamethasone plasma concentrations on post-surgery Day 1 ranged from 0.09 to 0.86 ng/mL and from 0.07 to 1.16 ng/mL following administration of DEXYCU 342 mcg and 517 mcg, respectively.

In the second study, dexamethasone plasma concentrations on post-surgery Day 1 ranged from 0.349 to 2.79 ng/mL following administration of DEXYCU 517 mcg. In both the studies, dexamethasone plasma concentrations declined over time and very few patients had quantifiable dexamethasone plasma concentrations at the final time point of sampling (Day 15 or Day 30).

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Clinical efficacy was evaluated in a randomized, double-masked, placebo-controlled trial (NCT02006888) in which subjects received either DEXYCU or placebo (vehicle). A dose of 5 microliters of DEXYCU (equivalent to 517 micrograms of dexamethasone), a dose equivalent to 342 micrograms of dexamethasone or vehicle was administered by the physician at the end of the surgical procedure. The primary efficacy endpoint for the study was the proportion of patients with anterior chamber cell clearing (i.e., cell score=0) on postoperative day (POD) 8.

The presence of anterior cells was assessed using a slit lamp binocular microscope up to 30 days post treatment. The percentage of patients with anterior chamber clearing at Day 8 was 20% in the placebo group, and 57%, and 60% in the 342 and 517 microgram treatment groups, respectively (Table 1). The percentage of subjects receiving rescue medication of ocular steroid or NSAID was significantly lower at Day 3, 8, 15 and 30 in the 342 and 517 microgram treatment groups compared to placebo (Table 2).

Table 1: Proportion of subjects with clearing of the anterior chamber cells by visit Treatments Difference and 97.5% CI Visits Placebo N=80 DEX342 N=158 DEX517 N=156 DEX342 vs Placebo DEX517 vs Placebo Subjects who received rescue medication were treated as failure. Day 1 7 (9%) 17 (11%) 24 (15%) 2% (-7%, 11%) 7% (-3%, 16%) Day 3 13 (16%) 60 (38%) 44 (28%) 22% (9%, 34%) 12% (0%, 24%) Day 8 16 (20%) 90 (57%) 94 (60%) 37% (24%, 50%) 40% (27%, 54%) Day 15 21 (26%) 83 (52%) 91 (58%) 26% (12%, 40%) 32% (18%, 46%) Day 30 28 (35%) 113 (72%) 103 (66%) 36% (22%, 51%) 31% (16%, 46%) Table 2: Proportion of subjects receiving rescue medications Visits Number (Percent) of Patients Receiving Rescue Medication, and 95% CI Placebo N=80 DEX342 N=158 DEX517 N=156 Subjects who received an ocular corticosteroid or NSAID in study eye.

Day 1 10 (13%); 6%, 22% 9 (6%); 3%, 10% 10 (6%); 3%, 12% Day 3 30 (38%); 27%, 49% 9 (6%); 3%, 10% 16 (10%); 6%,16% Day 8 40 (50%); 39%, 61% 12 (8%); 4%, 13% 16 (10%); 6%,16% Day 15 43 (54%); 42%, 65% 22 (14%); 9%, 20% 26 (17%); 11%, 24% Day 30 43 (54%); 42%, 65% 25 (16%); 10%, 22% 31 (20%); 14%, 27%

🧪 Nonclinical Toxicology 34 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to determine whether DEXYCU has the potential for carcinogenesis or mutagenesis. Fertility studies have not been conducted in animals.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 31 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to determine whether DEXYCU has the potential for carcinogenesis or mutagenesis. Fertility studies have not been conducted in animals.

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2.2 ) 6/2020

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPAL DISPLAY PANEL - 0.005 mL Vial Carton DEXYCU™ (dexamethasone intraocular suspension) 9% 0.005 mL dose in single dose vial for intraocular administration Please see enclosed full Prescribing Information for Instructions Rx Only NDC 71879-001-01 EYEPOINT™ PHARMACEUTICALS For Intraocular Injection Store at 20°C to 25°C (68°F to 77°F) PRINCIPAL DISPLAY PANEL - 0.005 mL Vial Carton

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

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

Medicare Part D (outpatient prescription) spending for Dexamethasone (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ 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 Dexamethasone. CMS lists 5 products for this generic; we show the highest-spend one. 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
$4.52M
Claims incl. refills
379.2K
Beneficiaries
287.4K
Spend / beneficiary
$15.74
Spend / claim
$11.92
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 Dexamethasone — the ingredient across all brands.

Top reported reactions

Fatigue17,772
Diarrhoea17,598
Nausea14,726
Plasma Cell Myeloma14,363
Pneumonia14,123
Death13,769
Neutropenia11,946

Age at onset

Neonate725
Infant410
Child1,670
Adolescent801
Adult25,864
Elderly28,087

Reporter sex

308,305 reports
Male · 51%
Female · 48%
Unknown · 1%

Serious outcomes

Hospitalization118,124
Life-threatening22,959
Disabling6,508
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 30,273 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 No longer marketed (per FDA listing data)
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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
EyePoint Pharmaceuticals US, 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.
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.
← 71875-0800-40 · TRIPLE 71881-0400-12 · Aimmune →
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.