EPIOXA CROSS-LINKING

Manufacturer
Glaukos Corporation
Effective date
2025-11-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 21:55:37

Label at a glance#

ProductEPIOXA CROSS-LINKING
Active ingredientRIBOFLAVIN 5'-PHOSPHATE
Label structure15 sections

Indications and uses

EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles.

Dosage and administration

EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use. EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use. EPIOXA HD and EPIOXA are for use with the O 2 n System and Boost Goggles only. Refer to the O 2 n System Operator's Manual and Boost Goggles User Guide for device instructions. Apply topical anesthetic and insert a lid speculum. Usi...

Storage and handling

EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239%, and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177%, are clear, yellow, ophthalmic solutions. EPIOXA HD and EPIOXA are co-packaged in an Epithelium-on Cross-linking Kit (NDC 25357-024-01) containing: One single-dose glass syringe containing 2 mL of EPIOXA HD 0.239% packaged in a foil pouch. One single-dose glass syringe containing 2 mL of ...

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and the Boost Goggles.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Important Administration Instructions

SPL UNCLASSIFIED SECTION

EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use.

EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use.

EPIOXA HD and EPIOXA are for use with the O2n System and Boost Goggles only.

Refer to the O2n System Operator's Manual and Boost Goggles User Guide for device instructions.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

3.1 EPIOXA HD

SPL UNCLASSIFIED SECTION

Ophthalmic solution: 0.239% (2.39 mg/mL) of riboflavin 5'-phosphate in a clear, yellow, solution in a single-dose glass syringe.

3.2 EPIOXA

SPL UNCLASSIFIED SECTION

Ophthalmic solution: 0.177% (1.77 mg/mL) of riboflavin 5'-phosphate in a clear, yellow, solution in a single-dose glass syringe.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

4.1 Hypersensitivity

SPL UNCLASSIFIED SECTION

EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA.

4.2 Aphakic and Pseudophakic Patients

SPL UNCLASSIFIED SECTION

Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Herpetic Keratitis

SPL UNCLASSIFIED SECTION

Corneal collagen cross-linking should be used with caution in patients with a history of herpetic keratitis due to the potential for reactivation of herpes keratitis.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following clinically significant adverse reactions are described elsewhere in the labeling:

Herpetic keratitis [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

CLINICAL TRIALS EXPERIENCE SECTION

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 safety of EPIOXA HD and EPIOXA in the epithelium-on corneal collagen cross-linking procedure with UV-A irradiation and supplemental oxygen was evaluated in two randomized, parallel-group, sham procedure/vehicle-controlled trials. Study eyes were randomized in a 2:1 treatment allocation to receive corneal collagen cross-linking (CXL) or sham procedure/vehicle control at the baseline visit. In both trials, CXL-treated eyes were followed for 12 months.

Safety data were obtained from a total of 389 CXL-treated eyes.

The most commonly reported adverse reaction in CXL-treated eyes was conjunctival hyperaemia (31%). Other adverse reactions occurring in 5% to 25% of CXL-treated eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, lacrimation increased, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

Risk Summary

Animal development and reproduction studies have not been conducted with EPIOXA HD and EPIOXA with the O2n System and Boost Goggles. Since it is not known whether the epithelium-on corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.

8.2 Lactation

LACTATION SECTION

Risk Summary

There are no data on the presence of EPIOXA HD or EPIOXA in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for the EPIOXA HD and EPIOXA epithelium-on corneal collagen cross-linking procedure and any potential adverse effects on the breastfed child from the EPIOXA HD and EPIOXA epithelium-on corneal collagen cross-linking procedure or from the underlying maternal condition.

8.4 Pediatric Use

PEDIATRIC USE SECTION

The safety and effectiveness of EPIOXA HD and EPIOXA for the treatment of keratoconus have been established in pediatric patients aged 13 years and older.

8.5 Geriatric Use

GERIATRIC USE SECTION

No patients enrolled in the clinical trials were 65 years of age or older.

11 DESCRIPTION

DESCRIPTION SECTION

EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239% and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177% contain riboflavin 5'-phosphate, a photoenhancer, for topical ophthalmic use.

EPIOXA HD 0.239% is a clear, yellow, sterile buffered solution containing 2.39 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.7 to 7.7 and the osmolality is 200 mOsm/kg to 260 mOsm/kg. Each mL of solution contains 2.50 mg of riboflavin 5'-phosphate sodium (equivalent to 1.97 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are hydroxypropyl methylcellulose, sodium chloride, dibasic sodium phosphate dihydrate, edetate disodium dihydrate, tromethamine, monobasic sodium phosphate dihydrate, benzalkonium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

EPIOXA 0.177% is a clear, yellow, sterile buffered solution containing 1.77 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.5 to 7.5 and the osmolality is 330 mOsm/kg to 400 mOsm/kg. Each mL of solution contains 1.85 mg of riboflavin 5'-phosphate sodium (equivalent to 1.46 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are sodium chloride, dibasic sodium phosphate dihydrate, tromethamine, monobasic sodium phosphate dihydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

The molecular formula for riboflavin 5'-phosphate sodium (Vitamin B2) is C17H20N4NaO9P with a molecular weight of 478.33 g/mol.

Chemical StructureChemical Structure

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Riboflavin 5'-phosphate sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways.

Under the conditions used for corneal collagen cross-linking, riboflavin 5'-phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

The pharmacodynamics of EPIOXA HD and EPIOXA have not been characterized.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

The pharmacokinetics of EPIOXA HD and EPIOXA have not been characterized.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenicity

Animal studies have not been conducted to determine the carcinogenic potential of photoexcited riboflavin.

Mutagenesis

Photoexcited riboflavin has been shown to be genotoxic in the Ames Salmonella reverse mutation assay and in the SOS/umu test system.

The genotoxicity of riboflavin, in the absence of photoexcitation has been examined in vitro in bacterial reverse mutation assays, sister chromatid exchange assay, chromosomal aberration assays and in vivo in a mouse micronucleus study. The overall weight of evidence indicates that riboflavin, in the absence of photoexcitation, is not genotoxic.

Impairment of Fertility

Animal studies to determine the effects of the EPIOXA HD and EPIOXA epithelium-on corneal collagen cross-linking procedure on fertility were not conducted.

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

Two prospective, randomized, parallel-group, sham procedure/vehicle-controlled trials (Study 1 [NCT03442751] and Study 2 [NCT05759559]) were conducted to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) using riboflavin 5'-phosphate ophthalmic solutions with UV-A irradiation and supplemental oxygen in patients with keratoconus.

In both trials, eligible eyes were randomized to receive CXL treatment or sham procedure/vehicle control in a 2:1 treatment allocation at the baseline visit. Aphakic patients and pseudophakic patients without a UV-blocking intraocular lens were excluded. Both eyes of a patient could be enrolled in the trial; however, one eye was treated first, and the second eye was treated between 1 week and 3 months after the first eye. Eyes were evaluated at 1 day, 3 days, 1 week, and 1, 3, 6, and 12 months post-treatment.

In Study 1, eyes randomized to sham procedure/vehicle control were permitted to receive CXL treatment after month 6 and were followed an additional 6 months. The primary efficacy endpoint was at month 6 post-treatment and the secondary efficacy endpoint was at month 12 post-treatment. In Study 2, the primary efficacy endpoint was at month 12 post-treatment and the secondary efficacy endpoint was at month 6 post-treatment.

In Study 1, a total of 280 eyes of 201 patients were randomized into the trial, of which 279 eyes were treated: 189 eyes received CXL treatment and 90 eyes initially received sham procedure/vehicle control. A statistically significant treatment effect was demonstrated at month 6, based on the difference in change from baseline in maximum corneal curvature (Kmax) between the CXL treatment group and sham procedure/vehicle control group (Table 1).

Table 1. Study 1: Mean Baseline Kmax (D) and Change from Baseline Kmax (D)
VisitCXL Treatment
(N=189)
Sham Procedure/ Vehicle Control
(N=90)
Treatment Difference
(95% CI) P-value
Randomized eyes that received study treatment
Baseline* 59.4 (9.1)59.3 (9.1) 
Month 6† -0.3 (-0.6, -0.0)0.6 (0.2, 1.1)-1.0 (-1.5, -0.4) P<0.01
Month 12‡ -0.4 (-0.7, -0.2)0.7 (0.3, 1.1)-1.1 (-1.6, -0.6) P<0.01

* Mean (standard deviation) Kmax

† LS Mean change from baseline and corresponding 95% CIs obtained from a RMMM ANCOVA model with treatment as a factor and the baseline Kmax value and baseline keratoconus severity as covariates. Missing post-baseline Kmax data were handled by multiple imputation procedure for month 6.

‡ Missing post-baseline Kmax data were handled by last observation carried forward method for month 12 in Sham Procedure/Vehicle Control eyes that received CXL treatment after month 6.

In a subgroup analysis of patients in this trial at month 6, younger patients (< 29 years) experienced a treatment effect of -2.0 D, as a combination of improvement in the CXL treatment arm (-0.7 D) and deterioration in the sham procedure/vehicle control arm (1.3 D). Older patients (≥ 29 years) did not experience improvement at month 6 in either arm.

In Study 2, a total of 312 eyes of 208 patients were randomized into the trial, of which 312 eyes were treated: 200 eyes received CXL treatment and 112 eyes received sham procedure/vehicle control. A statistically significant treatment effect was demonstrated at month 12, based on the difference in change from baseline in Kmax between the CXL treatment group and sham procedure/vehicle control group (Table 2).

Table 2. Study 2: Mean Baseline Kmax (D) and Change from Baseline Kmax (D)
VisitCXL Treatment
(N=200)
Sham Procedure/ Vehicle Control
(N=112)
Treatment Difference
(95% CI) P-Value
Randomized eyes that received study treatment
Baseline* 58.0 (8.0)58.1 (8.6) 
Month 6† -0.4 (-0.6, -0.2)0.1 (-0.1, 0.4)-0.6 (-0.9, -0.2) P<0.01
Month 12† -0.5 (-0.7, -0.3)0.4 (0.1, 0.8)-1.0 (-1.3, -0.6) P<0.01

* Mean (standard deviation) Kmax

† LS Mean change from baseline and corresponding 95% CIs obtained from a RMMM ANCOVA model with treatment as a factor and the baseline Kmax value and baseline keratoconus severity and age stratum as covariates. Missing post-baseline Kmax data were handled by multiple imputation procedure.

In a subgroup analysis of patients in this trial at month 12, younger patients (< 30 years) experienced a treatment effect of -1.1 D, as a combination of improvement in the CXL treatment arm (-0.5 D) and deterioration in the sham procedure/vehicle control arm (0.5 D). Older patients (≥ 30 years) in the CXL treatment arm experienced comparable improvement (-0.6 D) as younger patients (-0.5 D); however, in the sham procedure/vehicle control arm, older patients (-0.0 D) did not deteriorate as much as younger patients (0.5 D).

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239%, and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177%, are clear, yellow, ophthalmic solutions. EPIOXA HD and EPIOXA are co-packaged in an Epithelium-on Cross-linking Kit (NDC 25357-024-01) containing:

  • One single-dose glass syringe containing 2 mL of EPIOXA HD 0.239% packaged in a foil pouch.
  • One single-dose glass syringe containing 2 mL of EPIOXA 0.177% packaged in a foil pouch.

STORAGE AND HANDLING SECTION

Store kit refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Minimize exposure of the syringes to light once removed from their protective packaging.

For topical ophthalmic use. Single-dose only. Discard syringes after use.

EPIOXA HD and EPIOXA are for use only with the O2n System, the single-use O2n System Treatment Activation Card, and Boost Goggles.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

  • Advise patients that there may be discomfort in the treated eye and that sunglasses may help with light sensitivity.
  • Instruct patients that they should contact their physician immediately if they experience severe pain in the treated eye or any sudden decrease in their vision.

SPL UNCLASSIFIED SECTION

EPIOXA HD, EPIOXA, the O2n System, and Boost Goggles are marketed by:

Avedro, a Glaukos company
30 North Avenue
Burlington, MA 01803
USA

Issued 10/2025
ML-000159 Rev 1

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25357-024-01

Rx Only

Epithelium-on Cross-linking Kit

Epioxa™ HD
(riboflavin 5'- phosphate ophthalmic solution) 0.239%

co-packaged with

Epioxa™
(riboflavin 5'- phosphate ophthalmic solution) 0.177%

For Topical Ophthalmic Use Only

Use only with O2n™ System, O2n™ System Single-use Treatment
Activation Card, and Boost Goggles®.
Do NOT use if damaged. Single-dose. Discard unused portion.

GLAUKOS®

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2727375{1 (riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic Solution [Epioxa]) / 1 (riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic Solution [Epioxa]) } Pack [Epioxa Cross-linking Kit]BPCK3
2727374{1 (riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic Solution) / 1 (riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic Solution) } PackGPCK3
2727368Epioxa 0.177 % Ophthalmic SolutionPSN3
2727375Epioxa Epithelium-on Cross-linking KitPSN3
2727373Epioxa HD 0.239 % Ophthalmic SolutionPSN3
2727374riboflavin 5'-phosphate 0.177 % (1) / 0.239 % (1) Ophthalmic Solution, Epithelium-on Cross-linking KitPSN3
2727363riboflavin 5'-phosphate 0.177 % Ophthalmic SolutionPSN3
2727371riboflavin 5'-phosphate 0.239 % Ophthalmic SolutionPSN3
2727368riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic Solution [Epioxa]SBD3
2727373riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic Solution [Epioxa]SBD3
2727363riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic SolutionSCD3
2727371riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic SolutionSCD3
2727368Epioxa (as riboflavin 5'-phosphate sodium) 0.177 % Ophthalmic SolutionSY3
2727375Epioxa Epithelium-on Cross-linking KitSY3
2727373Epioxa HD (as riboflavin 5'-phosphate sodium) 0.239 % Ophthalmic SolutionSY3
2727363riboflavin 5'-phosphate (as riboflavin 5'-phosphate sodium) 0.177 % Ophthalmic SolutionSY3
2727371riboflavin 5'-phosphate (as riboflavin 5'-phosphate sodium) 0.239 % Ophthalmic SolutionSY3
2727374riboflavin 5'-phosphate 0.177 % Ophthalmic Solution (1) / riboflavin 5'-phosphate 0.239 % Ophthalmic Solution (1) Epithelium-on Cross-linking KitSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
RIBOFLAVIN 5'-PHOSPHATE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e6383094-adb3-4e58-af3e-6e58e32b9740Product name220210330

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25357-024-01EPIOXA CROSS-LINKING1 in 1 CARTONKIT13
25357-026-01EPIOXA CROSS-LINKING1 in 1 POUCHSOLUTION/ DROPS2.39 mg in 1mL3
25357-026-01EPIOXA CROSS-LINKING2 mL in 1 SYRINGE, GLASSSOLUTION/ DROPS2 mL2.39 mg in 1mL3
25357-027-01EPIOXA CROSS-LINKING2 mL in 1 SYRINGE, GLASSSOLUTION/ DROPS2 mL1.77 mg in 1mL3
25357-027-01EPIOXA CROSS-LINKING1 in 1 POUCHSOLUTION/ DROPS1.77 mg in 1mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25357-024-01EA - Each25357-024ba2a7a85-7c10-4c99-9434-8e628a9d2c4712026-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25357-02425357-024-01
25357-02625357-026-01
25357-02725357-027-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
RIBOFLAVIN 5'-PHOSPHATE7N464URE7EACTIB
RIBOFLAVIN 5'-PHOSPHATE7N464URE7EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-10-30monthly-update2026-06-03 17:43:19

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219910-001EPIOXA HD/EPIOXA KITRIBOFLAVIN 5'-PHOSPHATE SODIUMEQ 0.239% BASE/ML;EQ 0.177% BASE/MLSOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219910-001NP2028-10-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219910-001EPIOXA HD/EPIOXA KITEQ 0.239% BASE/ML;EQ 0.177% BASE/MLSOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-1784e616aacf4f…
2026-08-18 06:07:402026-07N219910-001EPIOXA HD/EPIOXA KITEQ 0.239% BASE/ML;EQ 0.177% BASE/MLSOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219910-001EPIOXA HD/EPIOXA KITEQ 0.239% BASE/ML;EQ 0.177% BASE/MLSOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219910-001EPIOXA HD/EPIOXA KIT0.239%;0.177%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219910-001EPIOXA HD/EPIOXA KITEQ 0.239% BASE/ML;EQ 0.177% BASE/MLSOLUTION/DROPS / OPHTHALMICRLD, RS2025-10-17a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219910-001NP2028-10-1784e616aacf4f…
2026-08-18 06:07:402026-07N219910-001NP2028-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219910-001NP2028-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219910-001NP2028-10-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219910-001NP2028-10-17a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPIOXA CROSS-LINKINGRIBOFLAVIN 5-PHOSPHATE OPHTHALMICGlaukos Corporation13cefc46-337c-41a3-b113-106bfe553bbb2025-11-18Warnings, Adverse reactionsExact identifier
ndc (package): 25357-026-01
ndc (package): 25357-024-01
ndc (package): 25357-027-01
ndc (product): 25357-024
ndc11 (package): 25357002601
ndc11 (package): 25357002401
ndc11 (package): 25357002701
spl id: d8f31876-b83b-4535-b2c2-d66210c14b15
spl set id: 13cefc46-337c-41a3-b113-106bfe553bbb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.