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Inveltys Loteprednol Etabonate 10 mg/mL Suspension, 1 bottle — NDC 0065-9307-04 (Billing 00065-9307-04)

by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 2.8 mL in 1 BOTTLE, DROPPER

This is a package of 1 bottle of Inveltys Loteprednol Etabonate 10 mg/mL Suspension from Alcon Laboratories, Inc., no longer marketed (first marketed Apr 2026), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026. It is the main listing for this product, which comes in 2 package sizes.

NDC 00065-9307-04
🏷️ FDA NDC (as labeled) 0065-9307-04 billing pads the labeler segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $103.63/unit — full pricing hub ↓
Main listing for product 0065-9307 · Also comes in: 2.8 mL 0065-9307-05
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 0065-9307-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0065 labeler · 9307 product · 04 package
Package marketed since
Apr 16, 2026
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Barcode (UPC)
0300659307049
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 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) 0065-9307-04
Product NDC 0065-9307
11-digit billing NDC 00065930704
RxCUI 2055281, 2055286
UNII YEH1EZ96K6
UPC 0300659307049
Application # NDA210565
SPL Set ID bdd18e84-79b3-4c8b-a07f-eb06cf52e68c
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2026-04-16
Marketing end 2026-09-30
Route OPHTHALMIC
Dosage form SUSPENSION
Substance LOTEPREDNOL ETABONATE
Quick answers
  • RxCUI (RxNorm): 2055281
Why two NDCs? The FDA registers this code as 0065-9307-04 — 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 → 00065-9307-04. 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.

Clinical

📖 What it is MedlinePlus · NLM

Ophthalmic loteprednol products are used to treat different eye conditions: Loteprednol (Inveltys, Lotemax, Lotemax SM) is used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye). Loteprednol (Alrex) is used to reduce eye redness, itching, and swelling caused by seasonal allergies. Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenp...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is a steroid eye medicine. Depending on the product, it treats inflammation and pain after eye surgery, steroid-responsive eye inflammation, seasonal allergic conjunctivitis (Al...
  • Wash your hands first and follow the directions for your product. Suspensions need to be shaken, and gels need the closed bottle inverted and shaken once. If you use other eye drop...
  • Eye pain and clouding behind the lens were the most common in trials after surgery, and surgery may have caused them. Steroid eye medicines can also raise eye pressure or cause cat...
  • Call if your vision changes, your eye pain or redness gets worse, or you see discharge. Also call if symptoms do not improve after two days when using the suspension for inflammati...
📖 Read our full Loteprednol Etabonate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 · Q2 2026 $103.63 $290.16 / 2.8 ml
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
00065-9307-04 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 2.8 mL in 1 BOTTLE, DROPPER 2026-04-16 Sep 30, 2026 Discontinued by firm
00065-9307-05 0065-9307-05 1 BOTTLE, DROPPER in 1 CARTON / 2.8 mL in 1 BOTTLE, DROPPER Sample 2026-04-16 Sep 30, 2026 Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 1 bottle — 1 bottle, dropper in 1 carton / 2.8 ml in 1 bottle, dropper.
How does this package differ from NDC 00065-9307-05?
Both are Inveltys Loteprednol Etabonate 10 mg/mL Suspension — the drug itself is identical. This page's package is the 1 bottle one, while NDC 00065-9307-05 is the 1 bottle package.
What NDC number is used to bill for this package of Inveltys Loteprednol Etabonate 10 mg/mL Suspension?
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
Inveltys 10 mg/mLthis 00065-9307-04 Alcon 1 bottle — — Discontinued —
Inveltys 10 mg/mL 71571-0121-20 ALCON 2.8 ml — — Discontinued —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 22, 2018 RLD RS ⏳ ~6.6 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 9056057 — method of use (U-2491)
US 9532955 — method of use (U-2491)
US 10058511 — method of use (U-2492)
US 11219597 — method of use (U-3278)
US 11219597 — method of use (U-3279)
US 10864219 — method of use (U-3011)
US 9737491 — method of use (U-2492)
US 9827191 — method of use (U-2493)
US 12115246 — method of use (U-4025)
US 10688045 — drug product
US 11642317 — drug product
US 10646437 — drug product
US 9393213 — drug product
US 11872318 — drug product
2018 2020 2022 2024 2026 2028 2030 2032
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 (14)
PatentTypeUse codeExpires
US 9056057 ↗ Method of use U-2491 May 3, 2033
US 9532955 ↗ Method of use U-2491 May 3, 2033
US 10058511 ↗ Method of use U-2492 May 3, 2033
US 11219597 ↗ Method of use U-3278 May 3, 2033
US 11219597 ↗ Method of use U-3279 May 3, 2033
US 10864219 ↗ Method of use U-3011 May 3, 2033
US 9737491 ↗ Method of use U-2492 May 3, 2033
US 9827191 ↗ Method of use U-2493 May 3, 2033
US 12115246 ↗ Method of use U-4025 May 3, 2033
US 10688045 ↗ Drug product — May 3, 2033
US 11642317 ↗ Drug product — May 3, 2033
US 10646437 ↗ Drug product — May 3, 2033
US 9393213 ↗ Drug product — May 3, 2033
US 11872318 ↗ Drug product — May 3, 2033
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
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 Loteprednol Etabonate 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA210565 (NDA)
Labeler code00065
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio55 products on file

More NDCs from Alcon Laboratories, Inc. labeler code 00065

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 📋 Description 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )

⏱️ Dosage and Administration 129 words ▾

2 DOSAGE AND ADMINISTRATION Shake for one to two seconds before using. ( 2 ) Instill one to two drops of INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2 )

2.1Dosage Information Instill one to two drops of INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.

2.2Administration Instructions Instruct patient to wash hands well before each use. Shake for one to two seconds before using. If the patient is using other eye drops in addition to INVELTYS , advise the patient to wait at least 5 minutes between instillation of INVELTYS and other eye drops.

💊 Dosage Forms and Strengths 22 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic suspension containing loteprednol etabonate 1% (10mg/mL). Ophthalmic suspension containing loteprednol etabonate 1% (10mg/mL). ( 3 )

⛔ Contraindications 77 words ▾

4 CONTRAINDICATIONS INVELTYS is contraindicated in most 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 diseases of ocular structures. INVELTYS is contraindicated in most 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 diseases of ocular structures.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation.

( 5.2 ) Delayed Healing : 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 topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

( 5.3 ) Bacterial Infections : 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. ( 5.4 ) Viral Infections : Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.5 ) Fungal Infections : 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.

( 5.6 )

5.1Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.

5.2Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.

5.3Delayed Healing 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 topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

5.4Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

5.5Viral Infections Use of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

5.6Fungal Infections 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 cultures should be taken when appropriate.

5.7Risk of Contamination Do not to allow the dropper tip to touch any surface, as this may contaminate the suspension.

5.8Contact Lens Wear The preservative in INVELTYS may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of INVELTYS and may be reinserted 15 minutes following administration.

🤒 Adverse Reactions 185 words ▾

6 ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 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 trials 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 most common adverse drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular opacification, both reported in 1% of patients. These reactions may have been the consequence of the surgical procedure.

👥 Use in Specific Populations 94 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug.

8.2Lactation Risk Summary INVELTYS is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in exposure of the child to INVELTYS .

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

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

🤰 Pregnancy 27 words ▾

8.1Pregnancy Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug.

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 18 words ▾

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

🧬 Clinical Pharmacology 173 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established.

However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

12.3Pharmacokinetics Loteprednol etabonate is lipid soluble and can penetrate into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites, PJ-91 and PJ-90.

Following twice-daily unilateral topical ocular dosing of INVELTYS for 14 days in healthy subjects, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1 ng/mL) at all timepoints.

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established.

However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a sterile ophthalmic suspension. It is supplied in a white low-density polyethylene bottle, with a natural low-density polyethylene tip, a pink polypropylene cap and a tamper-evident seal imprinted around the neck in the following size: 2.8 mL in a 5 mL bottle (NDC 0065-9307-04) Storage and Handling Do not use if tamper-evident seal is damaged Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze.

📋 Description 83 words ▾

11 DESCRIPTION Loteprednol etabonate is a corticosteroid. Its chemical name is chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Its molecular formula is C 24 H 31 ClO 7 and its chemical structure is: C 24 H 31 ClO 7 Mol.

Wt. 467.0 INVELTYS (loteprednol etabonate ophthalmic suspension) 1% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Each mL contains: ACTIVE: loteprednol etabonate 10 mg (1%) INACTIVES: glycerin, sodium citrate dihydrate, Poloxamer 407, sodium chloride, edetate disodium dihydrate, citric acid, and water for injection PRESERVATIVE: benzalkonium chloride 0.01%

🧬 Pharmacokinetics 88 words ▾

12.3Pharmacokinetics Loteprednol etabonate is lipid soluble and can penetrate into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites, PJ-91 and PJ-90.

Following twice-daily unilateral topical ocular dosing of INVELTYS for 14 days in healthy subjects, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1 ng/mL) at all timepoints.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES Clinical efficacy was evaluated in 2 multi-centered, randomized, double-masked, placebo-controlled trials in which patients with an anterior cell grade greater than or equal to "2" (a cell count of 6 or higher using a slit-lamp biomicroscope) after cataract surgery were assigned to INVELTYS or placebo (vehicle) following surgery (NCT # 02163824 and NCT # 02793817). One to two drops of INVELTYS or vehicle was self-administered twice a day for 14 days, beginning the day after surgery. Complete resolution of inflammation (a cell count of 0 maintained through day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through day 15 without rescue medication) was assessed 4, 8, and 15 days post-surgery.

In the intent-to-treat analysis of both studies, a significant benefit was seen in the INVELTYS -treated group for complete resolution of ocular inflammation at Days 8 and 15, and complete resolution of pain at Days 4, 8, and 15, when compared with placebo. The consolidated clinical trial results are provided below. Figure 1 Consolidated Clinical Trial Data: Percent of Patients with Complete Resolution of Anterior Chamber Cells (Cell Count = 0) at Days 8 and 15 * p-values < 0.01 for treatment comparisons Figure 2 Consolidated Clinical Trial Data: Percent of Patients Who Were Pain Free at Days 4, 8, and 15 * p-values < 0.01 for treatment comparisons

🧪 Nonclinical Toxicology 61 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma thymidine kinase (tk) assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 58 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma thymidine kinase (tk) assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE INVELTYS [in-vel-tis] (loteprednol etabonate ophthalmic suspension) 1% for topical ophthalmic use This Instructions for Use contains information on how to properly administer INVELTYS. Important Information You Need to Know Before Using INVELTYS INVELTYS is for use in the eye only. Wash your hands before using INVELTYS.

Do not use if the tamper-evident seal is not intact. Do not let the INVELTYS dropper tip touch your eye, fingers, or any other surfaces to avoid contamination or injury to your eye. Use INVELTYS exactly as your healthcare provider tells you to.

If you are using INVELTYS with other eye (ophthalmic) medicines, you should wait at least 5 minutes between using INVELTYS and the other medicine. If you wear contact lenses, remove them before using INVELTYS. Put the pink cap back on INVELTYS after each use.

Follow Steps 1 to 6 each time you use INVELTYS. Step 1: Wash your hands well. Step 2: Shake the INVELTYS bottle for 1 to 2 seconds (See Figure A) .

Figure A Step 3: Remove the pink cap from the top of the INVELTYS dropper by turning it counterclockwise (See Figure B) . Keep the pink cap. Do not let the INVELTYS dropper tip touch your eye, fingers, or any other surface.

Figure B Step 4: Turn the INVELTYS bottle upside down (See Figure C) . Figure C Step 5: Tilt your head back. Hold the bottle directly above your affected eye.

Squeeze the middle of the INVELTYS bottle gently to put 1 to 2 drops (follow your doctor’s recommendation) into the affected eye (See Figure D) . Figure D Step 6: Place the pink cap back onto the INVELTYS bottle and tighten by turning clockwise (See Figure E) . Figure E If you use contact lenses, wait for 15 minutes before placing them back in.

How should I store INVELTYS? Store INVELTYS upright at 59ºF to 77ºF (15ºC to 25ºC). Do not freeze Keep INVELTYS and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA Revised: 04/2026 300074560-1125

📄 Package Label / Principal Display Panel 198 words ▾

PRINCIPAL DISPLAY PANEL - 2.8 mL Bottle Carton NDC 0065-9307-04 Rx Only INVELTYS® (loteprednol etabonate ophthalmic suspension)1% Sterile 2.8 mL NDC 0065-9307-04 Rx Only INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% FOR TOPICAL APPLICATION IN THE EYE. Sterile 2.8 mL Alcon Dosage: See Prescribing Information. SHAKE FOR 1 to 2 SECONDS Storage: Store upright at 1 5°C to 25°C (59°F to 77°F).

DO NOT FREEZE. DO NOT USE IF TAMPER-EVIDENT SEAL IS DAMAGED 300074557-1125 Store upright INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% NDC 0065-9307-04 Rx Only 2.8mL Sterile Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA 300074563-1125

PRINCIPAL DISPLAY PANEL - 2.8 mL Bottle Carton NDC 0065-9307-04 Rx Only INVELTYS® (loteprednol etabonate ophthalmic suspension)1% Sterile 2.8 mL NDC 0065-9307-05 Rx Only INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% FOR TOPICAL APPLICATION IN THE EYE. PROFESSIONAL SAMPLE Not for Retail Sale Sterile 2.8 mL Alcon Dosage: See Prescribing Information. SHAKE FOR 1 to 2 SECONDS Storage: Store upright at 15°C to 25°C (59°F to 77°F).

DO NOT FREEZE. DO NOT USE IF TAMPER-EVIDENT SEAL IS DAMAGED 300074556-1125 Store upright INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% NDC 0065-9307-05 Sample Rx Only 2.8mL Sterile Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA 300074565-1125

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 Inveltys — 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 Inveltys. 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
$200.2K
Claims incl. refills
540
Beneficiaries
384
Spend / beneficiary
$521.26
Spend / claim
$370.67
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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (00065-9307-05). 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?
Alcon Laboratories, 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.
← 00065-9305-01 · Alcon 00065-9308-05 · Alcon →
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.