EPIOXA CROSS-LINKING

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlaukos Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2535702401
1 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, GLASS

Annotations

Orange Book

N219910

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "OPHTHALMIC",
  "spl_meta": {
    "13cefc46-337c-41a3-b113-106bfe553bbb": {
      "match": "brand_token",
      "title": "EPIOXA CROSS-LINKING (RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC) KIT [GLAUKOS CORPORATION]",
      "spl_version": "3",
      "published_date": "2026-01-16"
    }
  },
  "productid": "25357-024_d8f31876-b83b-4535-b2c2-d66210c14b15",
  "productndc": "25357-024",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "219910",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.239% BASE/ML;EQ 0.177% BASE/ML",
        "product_no": "001",
        "approval_date": "Oct 17, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "EPIOXA CROSS-LINKING",
  "active_ingred_unit": null,
  "application_number": "NDA219910",
  "marketing_category": "NDA",
  "nonproprietary_name": "riboflavin 5-phosphate ophthalmic",
  "start_marketing_date": "20260116",
  "active_numerator_strength": null
}

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