FDA.reportPublic FDA data

EPIOXA CROSS-LINKING

Product NDC
25357-024
11-digit product format
253570024
Labeler code
25357
Product ID
25357-024_d8f31876-b83b-4535-b2c2-d66210c14b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
riboflavin 5-phosphate ophthalmic
Dosage form
KIT
Route
OPHTHALMIC
Labeler
Glaukos Corporation
Application
NDA219910
Marketing category
NDA
Marketing start
2026-01-16
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
2026-02-19 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
2026-02-19 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…

Additional Listing Data#

Finished product
Yes
Brand name base
EPIOXA CROSS-LINKING
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2727363Internal RxNorm lookup
2727368Internal RxNorm lookup
2727371Internal RxNorm lookup
2727373Internal RxNorm lookup
2727374Internal RxNorm lookup
2727375Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13cefc46-337c-41a3-b113-106bfe553bbbAvailable on FDA.report

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

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
application applno (NDA): 219910
application number: NDA219910
ndc (product): 25357-024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL 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]BPCK13cefc46-337c-41a3-b113-106bfe553bbb3
2727374{1 (riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic Solution) / 1 (riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic Solution) } PackGPCK13cefc46-337c-41a3-b113-106bfe553bbb3
2727368Epioxa 0.177 % Ophthalmic SolutionPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727375Epioxa Epithelium-on Cross-linking KitPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727373Epioxa HD 0.239 % Ophthalmic SolutionPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727374riboflavin 5'-phosphate 0.177 % (1) / 0.239 % (1) Ophthalmic Solution, Epithelium-on Cross-linking KitPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727363riboflavin 5'-phosphate 0.177 % Ophthalmic SolutionPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727371riboflavin 5'-phosphate 0.239 % Ophthalmic SolutionPSN13cefc46-337c-41a3-b113-106bfe553bbb3
2727368riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic Solution [Epioxa]SBD13cefc46-337c-41a3-b113-106bfe553bbb3
2727373riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic Solution [Epioxa]SBD13cefc46-337c-41a3-b113-106bfe553bbb3
2727363riboflavin 5'-phosphate 1.77 MG/ML Ophthalmic SolutionSCD13cefc46-337c-41a3-b113-106bfe553bbb3
2727371riboflavin 5'-phosphate 2.39 MG/ML Ophthalmic SolutionSCD13cefc46-337c-41a3-b113-106bfe553bbb3
2727368Epioxa (as riboflavin 5'-phosphate sodium) 0.177 % Ophthalmic SolutionSY13cefc46-337c-41a3-b113-106bfe553bbb3
2727375Epioxa Epithelium-on Cross-linking KitSY13cefc46-337c-41a3-b113-106bfe553bbb3
2727373Epioxa HD (as riboflavin 5'-phosphate sodium) 0.239 % Ophthalmic SolutionSY13cefc46-337c-41a3-b113-106bfe553bbb3
2727363riboflavin 5'-phosphate (as riboflavin 5'-phosphate sodium) 0.177 % Ophthalmic SolutionSY13cefc46-337c-41a3-b113-106bfe553bbb3
2727371riboflavin 5'-phosphate (as riboflavin 5'-phosphate sodium) 0.239 % Ophthalmic SolutionSY13cefc46-337c-41a3-b113-106bfe553bbb3
2727374riboflavin 5'-phosphate 0.177 % Ophthalmic Solution (1) / riboflavin 5'-phosphate 0.239 % Ophthalmic Solution (1) Epithelium-on Cross-linking KitSY13cefc46-337c-41a3-b113-106bfe553bbb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25357-024-01253570024011 KIT in 1 CARTON (25357-024-01) * 1 SYRINGE, GLASS in 1 POUCH (25357-026-01) / 2 mL in 1 SYRINGE, GLASS * 1 SYRINGE, GLASS in 1 POUCH (25357-027-01) / 2 mL in 1 SYRINGE, GLASS1 kit2026-01-16NoNoCurrent
25357-026-01253570026011 in 1 POUCHHistorical
25357-027-01253570027012 mL in 1 SYRINGE, GLASS2 mlHistorical