loteprednol etabonate 2 mg/mL Suspension/ Drops — NDC 60219-1366-3 (Billing 60219-1366-03)
This is a package of loteprednol etabonate 2 mg/mL Suspension/ Drops from Amneal Pharmaceuticals NY LLC, marketed since Dec 2024 and currently FDA-listed; retail pharmacies pay about $30.72 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 039105
- GCN: 95465
- GPI-14 (Medi-Span): 86300035101820
- HICL (First Databank): 018026
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 311381
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $30.717 | $153.59 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $25.86 | $129.30 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $43.89 | $219.44 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60219-1366-03 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE | 2024-12-18 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Loteprednol Etabonate 2 mg/mL 00574-4080-05 | Padagis | 1 bottle | $30.717 | AB | Availability likely | — |
| loteprednol etabonate 2 mg/mLthis 60219-1366-03 | Amneal | 1 bottle | $30.717 | AB | Availability likely | — |
| Loteprednol Etabonate 2 mg/mL 70244-0035-01 | Sentiss | 1 bottle | $30.717 | AB | Availability likely | — |
| Loteprednol Etabonate 2 mg/mL 72485-0653-05 | ARMAS | 1 bottle | $30.717 | AB | Availability likely | — |
| loteprednol etabonate 2 mg/mL 82260-0361-05 | Bausch | 1 bottle | $30.717 | AB | Availability likely | — |
| Alrex 2 mg/mL 24208-0353-01 | Bausch | 1 bottle | — | AB | FDA listed | — |
| loteprednol etabonate 2 mg/mL 60219-1367-06 | Amneal | 1 bottle | — | AB | FDA listed | — |
| Loteprednol Etabonate 2 mg/mL 85766-0193-05 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION SHAKE VIGOROUSLY BEFORE USING. One drop instilled into the affected eye(s) four times daily.
⛔ Contraindications ▾
CONTRAINDICATIONS Loteprednol etabonate, as with other ophthalmic corticosteroids, 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. Loteprednol etabonate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
⚠️ Warnings ▾
WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Reactions associated with ophthalmic steroids 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. Ocular adverse reactions occurring in 5% to 15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% to 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection and photophobia.
Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients.
These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with loteprednol etabonate ophthalmic suspension, the incidence of clinically significant increases in IOP (≥ 10 mm Hg) was 1% (1/133) with loteprednol etabonate ophthalmic suspension and 1% (1/135) with placebo.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Teratogenic effects Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis with 0.5 to 100 mg/kg/day resulted in embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥ 50 mg/kg/day) and teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses and cleft palate and umbilical hernia at ≥ 50 mg/kg/day).
Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day.
Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects.
Caution should be exercised when loteprednol etabonate ophthalmic suspension is administered to a nursing woman.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.
However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.
It is highly lipid soluble which enhances its penetration 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.
Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ 1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited (< 1 ng/ml) systemic absorption occurs with loteprednol etabonate ophthalmic suspension.
Clinical Studies In two double-masked, placebo-controlled six-week environmental studies of 268 patients with seasonal allergic conjunctivitis, loteprednol etabonate ophthalmic suspension, when dosed four times per day was superior to placebo in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Loteprednol etabonate ophthalmic suspension provided reduction in bulbar conjunctival injection and itching, beginning approximately 2 hours after instillation of the first dose and throughout the first 14 days of treatment.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Loteprednol etabonate ophthalmic suspension, 0.2% is a sterile, white to off-white uniform suspension essentially free from foreign particles filled in 10 mL low density polyethylene white opaque bottle with low density polyethylene white opaque nozzle and high density polyethylene pink cap. It is available as follows: 5 mL in 10 mL Bottle (Filled to 1/2 Capacity): NDC 60219-1366-3 10 mL in 10 mL Bottle: NDC 60219-1367-6 Storage: Store upright between 15° to 25°C (59° to 77°F). DO NOT FREEZE.
KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PINK PLASTIC BAND UNDER CAP IS BROKEN OR MISSING. Manufactured by: Amneal Pharmaceuticals Pvt.
Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2024-00
📋 Description ▾
DESCRIPTION Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a micronized sterile white to off-white crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol.
Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol Chemical name: Chloromethyl 11β, 17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate, 17-(ethyl carbonate). Each mL of Loteprednol etabonate ophthalmic suspension, 0.2% contains: ACTIVE: Loteprednol etabonate, 2 mg (0.2%) PRESERVATIVE ADDED: Benzalkonium chloride, 0.01% INACTIVES: Edetate disodium, glycerin, povidone K 90, tyloxapol and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH between 5.3 to 5.6.
The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. 1
💬 Information for Patients ▾
Information for Patients This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If redness or itching becomes aggravated, the patient should be advised to consult a physician.
Patients should be advised not to wear a contact lens if their eye is red. Loteprednol etabonate ophthalmic suspension should not be used to treat contact lens related irritation. The preservative in loteprednol etabonate ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients who wear soft contact lenses and whose eyes are not red , should be instructed to wait at least ten minutes after instilling loteprednol etabonate ophthalmic suspension before they insert their contact lenses.
⚠️ Precautions ▾
PRECAUTIONS General For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days 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. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
If this product is used for 10 days or longer, intraocular pressure should be monitored. 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. Information for Patients This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension.
If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear a contact lens if their eye is red. Loteprednol etabonate ophthalmic suspension should not be used to treat contact lens related irritation.
The preservative in loteprednol etabonate ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red , should be instructed to wait at least ten minutes after instilling loteprednol etabonate ophthalmic suspension before they insert their contact lenses. Carcinogenesis, 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 tk assay or in a chromosome aberration test in human lymphocytes or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (1,500 and 750 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. Pregnancy Teratogenic effects Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity.
The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis with 0.5 to 100 mg/kg/day resulted in embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥ 50 mg/kg/day) and teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses and cleft palate and umbilical hernia at ≥ 50 mg/kg/day). Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day.
Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.
Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. Caution should be exercised when loteprednol etabonate ophthalmic suspension is administered to a nursing woman.
🔬 Clinical Studies ▾
Clinical Studies In two double-masked, placebo-controlled six-week environmental studies of 268 patients with seasonal allergic conjunctivitis, loteprednol etabonate ophthalmic suspension, when dosed four times per day was superior to placebo in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Loteprednol etabonate ophthalmic suspension provided reduction in bulbar conjunctival injection and itching, beginning approximately 2 hours after instillation of the first dose and throughout the first 14 days of treatment.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, 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 tk assay or in a chromosome aberration test in human lymphocytes or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (1,500 and 750 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 60219-1366-3 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 5 mL Amneal Pharmaceuticals LLC NDC 60219-1367-6 Loteprednol Etabonate Ophthalmic Suspension, 0.2% Rx only 10 mL Amneal Pharmaceuticals LLC 1 2 3 4