Lifitegrast 50 mg/mL For Solution — NDC 59651-450-60 (Billing 59651-0450-60)
This is a package of Lifitegrast 50 mg/mL For Solution from Aurobindo Pharma Limited, marketed since Nov 2023 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 59651-450-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59651 labeler · 450 product · 60 package
- Package marketed since
- Nov 7, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5965145060 4
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1801835
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Lymphocyte Function-Associated Antigen-1 Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Ophthalmic lifitegrast is used to treat the signs and symptoms of dry eye disease. Lifitegrast is in a class of medications called lymphocyte function-associated antigen-1 (LFA-1) antagonist. Lifitegrast works by reducing the swelling in the eye tissues.
Read the full MedlinePlus article ↗- Xiidra is specifically approved to treat dry eye disease, which involves both the symptoms you feel — like irritation, stinging, or a gritty sensation — and the physical signs a do...
- What exactly is Xiidra treating — is it just for dry, uncomfortable eyes?
- Yes, that's actually one of the most commonly reported side effects of Xiidra — doctors call it dysgeusia, meaning an altered or unpleasant taste. It happens because the drops can...
- I keep getting a weird taste in my mouth after I use the drops. Is that normal?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lifitegrast — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 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 | 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 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 |
|---|---|---|---|---|
| 59651-0450-60 You're viewing this Main listing | 60 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / .2 mL in 1 AMPULE | 2023-11-07 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Xiidra 50 mg/mL 00078-0911-12 | Novartis | 12 pouches | $11.832 | — | Availability likely | — |
| Xiidra 50 mg/mL 24208-0911-12 | Bausch | 12 pouches | $11.832 | — | Availability likely | — |
| Lifitegrast 50 mg/mLthis 59651-0450-60 | Aurobindo | 60 pouches | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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 Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII HX1032V43M
Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from Aurobindo Pharma Limited labeler code 59651
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- Deferasirox 90 mg Granule NDC 59651-447-30
- Deferasirox 180 mg Granule NDC 59651-448-30
- Deferasirox 360 mg Granule NDC 59651-449-30
- Varenicline Kit NDC 59651-451-53
- Topiramate 15 mg Capsule NDC 59651-452-60
- Topiramate 25 mg Capsule NDC 59651-453-60
- Fexofenadine Hydrochloride and Pseudoephedrine 180 mg; 240 mg Tablet, Film Coated, Extended Release NDC 59651-454-31
- Colchicine .6 mg Tablet NDC 59651-455-01
- Carbidopa and Levodopa 10 mg; 100 mg Tablet NDC 59651-456-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lifitegrast ophthalmic solution 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Lifitegrast ophthalmic solution 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop of lifitegrast ophthalmic solution twice daily (approximately 12 hours apart) into each eye using a single-dose container. Discard the single-dose container immediately after using in each eye. Contact lenses should be removed prior to the administration of lifitegrast ophthalmic solution and may be reinserted 15 minutes following administration. One drop twice daily in each eye (approximately 12 hours apart).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing lifitegrast 50 mg/mL (5%). Ophthalmic solution containing lifitegrast 50 mg/mL (5%).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Lifitegrast is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see Adverse Reactions (6.2) ]. Hypersensitivity.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) ] The most common adverse reactions (incidence 5% to 25%) following the use of lifitegrast were instillation-site irritation, dysgeusia and decreased visual acuity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc., at 1-866-850-2876 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 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. In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had less than or equal to 3 months of treatment exposure.
One hundred-seventy patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5% to 25% of patients were instillation-site irritation, dysgeusia, and reduced visual acuity.
Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus, and sinusitis.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of lifitegrast. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rare serious cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, urticaria, allergic conjunctivitis, dyspnea, angioedema, and allergic dermatitis have been reported.
Eye swelling and rash have also been reported [see Contraindications (4) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on lifitegrast use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level).
Since human systemic exposure to lifitegrast following ocular administration of lifitegrast at the RHOD is low, the applicability of animal findings to the risk of lifitegrast use in humans during pregnancy is unclear [see Clinical Pharmacology (12.3) ] . Data Animal Data Lifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of lifitegrast, based on AUC.
No teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19. A fetal no observed adverse effect level (NOAEL) was not identified in the rabbit.
8.2Lactation Risk Summary There are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lifitegrast from ocular administration is low [see Clinical Pharmacology (12.3) ] . The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for lifitegrast and any potential adverse effects on the breastfed child from lifitegrast.
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 17 years have not been established.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on lifitegrast use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level).
Since human systemic exposure to lifitegrast following ocular administration of lifitegrast at the RHOD is low, the applicability of animal findings to the risk of lifitegrast use in humans during pregnancy is unclear [see Clinical Pharmacology (12.3) ] . Data Animal Data Lifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of lifitegrast, based on AUC.
No teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19. A fetal no observed adverse effect level (NOAEL) was not identified in the rabbit.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 17 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues.
In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.
12.3Pharmacokinetics In a subset of DED patients (n = 47) enrolled in a Phase 3 trial, the pre-dose (trough) plasma concentrations of lifitegrast were measured after 180 and 360 days of topical ocular dosing (one drop twice daily) with lifitegrast ophthalmic solution 5%. A total of nine of the 47 patients (19%) had plasma lifitegrast trough concentrations above 0.5 ng/mL (the lower limit of assay quantitation). Trough plasma concentrations that could be quantitated ranged from 0.55 ng/mL to 3.74 ng/mL.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues.
In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Lifitegrast ophthalmic solution 5% (50 mg/mL) is a sterile, clear, colorless to slightly brownish-yellow colored solution and is supplied in a foil pouch containing 5 low-density polyethylene 0.2 mL single-dose containers. 5 x 0.2 mL single-dose containers Packaged in a pouch NDC 59651-450-05 60 x 0.2 mL single-dose containers Packaged in a carton (12 pouches x 5 single-dose containers) NDC 59651-450-60 Storage: Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Store single-dose containers in the original foil pouch.
📋 Description ▾
11 DESCRIPTION The chemical name for lifitegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid. The molecular formula of lifitegrast is C 29 H 24 Cl 2 N 2 O 7 S and its molecular weight is 615.5 g/mol. The structural formula of lifitegrast is: *Chiral center Lifitegrast is a white to off-white powder, which is practically insoluble in water.
Lifitegrast ophthalmic solution 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist supplied as a sterile, clear, colorless to slightly brownish-yellow colored, isotonic solution of lifitegrast with a pH of 7.0 to 8.0 and an osmolality range of 200 to 330 mOsmol/kg. Lifitegrast ophthalmic solution contains Active: lifitegrast 50 mg/mL; Inactives: sodium chloride, dibasic sodium phosphate anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.
Lifitegrast ophthalmic solution 5% figure1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Handling the Single-Dose Container Advise patients not to touch the tip of the single-dose container to their eye or to any surface, in order to avoid eye injury or contamination of the solution. Use with Contact Lenses Advise patients that contact lenses should be removed prior to administration of lifitegrast ophthalmic solution and can be reinserted 15 minutes after administration [see Dosage and Administration (2) ].
Administration Advise patients that the solution from one single-dose container is to be used immediately after opening. It can be used to dose both eyes. The single-dose container, including any remaining contents should be discarded immediately after administration [see Dosage and Administration (2) ].
Storage Information Instruct patients to store single-dose containers in the original foil pouch until ready to use [see How Supplied/Storage and Handling (16) ] . Dispense with Patient Information and Instructions for Use available at: https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics In a subset of DED patients (n = 47) enrolled in a Phase 3 trial, the pre-dose (trough) plasma concentrations of lifitegrast were measured after 180 and 360 days of topical ocular dosing (one drop twice daily) with lifitegrast ophthalmic solution 5%. A total of nine of the 47 patients (19%) had plasma lifitegrast trough concentrations above 0.5 ng/mL (the lower limit of assay quantitation). Trough plasma concentrations that could be quantitated ranged from 0.55 ng/mL to 3.74 ng/mL.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of lifitegrast for the treatment of DED were assessed in a total of 1181 patients (1067 of which received lifitegrast 5%) in four 12-week, randomized, multi-center, double-masked, vehicle-controlled studies. Patients were randomized to lifitegrast or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial tears was not allowed during the studies.
The mean age was 59 years (range, 19 to 97 years). The majority of patients were female (76%). Enrollment criteria included minimal signs (i.e., Corneal Fluorescein Staining and non-anesthetized Schirmer Tear Test) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort Score) severity scores at baseline.
Effects on Symptoms of Dry Eye Disease Eye dryness score was rated by patients using a visual analogue scale (0 = no discomfort, 100 = maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in EDS favoring lifitegrast was observed in all studies at Day 42 and Day 84 (see Figure 1).
Figure 1: Mean Change (SD) from Baseline and Treatment Difference (Lifitegrast – Vehicle) in Eye Dryness Score in 12-Week Studies in Patients with Dry Eye Disease [1] Based on analysis of covariance (ANCOVA) model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2 to 4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one lifitegrast-treated subject who did not have a baseline value was excluded from analysis.
Effects on Signs of Dry Eye Disease Inferior fluorescein corneal staining score (ICSS) (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2, and 2.4 in Studies 3 and 4. At Day 84, a larger reduction in ICSS favoring lifitegrast was observed in three of the four studies (see Figure 2).
Figure 2: Mean Change (SD) from Baseline and Treatment Difference (Lifitegrast – Vehicle) in Inferior Corneal Staining Score in 12-Week Studies in Patients with Dry Eye Disease [1] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2 to 4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one vehicle-treated subject who did not have a study eye designated was excluded from analysis.
Lifitegrast ophthalmic solution 5% Figure1 Lifitegrast ophthalmic solution 5% Figure2
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast. Mutagenesis Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse micronucleus assay.
In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary cells), lifitegrast was positive at the highest concentration tested, without metabolic activation. Impairment of Fertility Lifitegrast administered at IV doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the RHOD of lifitegrast ophthalmic solution, 5%) had no effect on fertility and reproductive performance in male and female-treated rats.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast. Mutagenesis Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse micronucleus assay.
In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary cells), lifitegrast was positive at the highest concentration tested, without metabolic activation. Impairment of Fertility Lifitegrast administered at IV doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the RHOD of lifitegrast ophthalmic solution, 5%) had no effect on fertility and reproductive performance in male and female-treated rats.
📄 Patient Package Insert ▾
PATIENT INFORMATION Lifitegrast (lif i TEG rast) Ophthalmic Solution 5% for topical ophthalmic use What is lifitegrast ophthalmic solution? Lifitegrast ophthalmic solution is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED). It is not known if lifitegrast ophthalmic solution is safe and effective in children under 17 years of age.
Do not use lifitegrast ophthalmic solution: If you are allergic to lifitegrast or any of the other ingredients in lifitegrast ophthalmic solution, see "What are the ingredients in lifitegrast ophthalmic solution?" Before you use lifitegrast ophthalmic solution, tell your doctor if you: are using any other eye drops wear contact lenses are pregnant or plan to become pregnant. It is not known if lifitegrast ophthalmic solution will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if lifitegrast ophthalmic solution passes into your breast milk.
Talk to your doctor about the best way to feed your baby if you use lifitegrast ophthalmic solution. How should I use lifitegrast ophthalmic solution? See the complete Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use lifitegrast ophthalmic solution.
Use lifitegrast ophthalmic solution as your doctor tells you. Use one drop of lifitegrast ophthalmic solution in each eye, two times each day, about 12 hours apart. Use lifitegrast ophthalmic solution right away after opening.
Throw away the single-dose container and any unused solution after you have applied the dose to both eyes. Do not save any unused lifitegrast ophthalmic solution for later. What are the possible side effects of lifitegrast ophthalmic solution?
The most common side effects of lifitegrast ophthalmic solution include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia). Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue. These are not all the possible side effects of lifitegrast ophthalmic solution.
Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1-800-FDA-1088. How should I store lifitegrast ophthalmic solution?
Store lifitegrast ophthalmic solution at room temperature between 20°C to 25°C (68°F to 77°F). Store lifitegrast ophthalmic solution in the original foil pouch to protect it from light. Do not open the lifitegrast ophthalmic solution foil pouch until you are ready to use the eye drops.
Return unused single-dose containers to their original foil pouch to protect from excessive light exposure. Keep lifitegrast ophthalmic solution and all medicines out of the reach of children. General information about the safe and effective use of lifitegrast ophthalmic solution.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about lifitegrast ophthalmic solution that is written for health professionals. Do not use lifitegrast ophthalmic solution for a condition for which it was not prescribed.
Do not give lifitegrast ophthalmic solution to other people, even if they have the same symptoms you have. It may harm them. What are the ingredients in lifitegrast ophthalmic solution?
Active ingredient: lifitegrast Inactive ingredients: sodium chloride, dibasic sodium phosphate anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. For more information, go to www.aurobindousa.com or call 1-866-850-2876. This Patient Information has been approved by the U.S.
Food and Drug Administration. Dispense with Patient Information and Instructions for Use available at: https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufac… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% Container Pouch Label NDC 59651-450-05 Lifitegrast Ophthalmic Solution 5% For Topical Application to the Eye Only Sterile, Preservative-Free 5 single-dose containers Rx Only (0.2 mL each) Lifitegrast ophthalmic solution 5% Figure11
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5% – Container-Carton Label NDC 59651-450-60 Rx only Lifitegrast Ophthalmic Solution 5% For Topical Application to the Eye Only 60 Single-Dose Containers: 12 pouches x 5 single-dose containers (0.2 mL each) Aurobindo Lifitegrast ophthalmic solution 5% Figure12
Medicare Part D spend CMS · PART D · 2026 (Q1)
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| NDC identity (package / product / labeler codes) | ✓ Available |
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