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United States · US · US:68803-612_4fa726e6-84c6-0f28-e063-6294a90aafe9

VISIONBLUE

Orange BookUNIISPLATC S01KX02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
CountryUS (United States)
ATC codeS01KX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6880361210
    10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
I2ZWO3LS3M
TRYPAN BLUE
RxCUI 10878
Orange Book
N021670
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "I2ZWO3LS3M",
    "rxcui": "10878",
    "inchikey": "GLNADSQYFUSGOU-GPTZEZBUSA-J",
    "display_name": "TRYPAN BLUE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAOCULAR; OPHTHALMIC",
  "spl_meta": {
    "a44bc2ef-3d7f-4125-a7f7-c5969b1b4142": {
      "match": "brand_token",
      "title": "VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.]",
      "spl_version": "23",
      "published_date": "2026-04-20"
    }
  },
  "productid": "68803-612_4fa726e6-84c6-0f28-e063-6294a90aafe9",
  "productndc": "68803-612",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021670",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.06%",
        "product_no": "001",
        "approval_date": "Dec 16, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRYPAN BLUE",
  "proprietary_name": "VISIONBLUE",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA021670",
  "marketing_category": "NDA",
  "nonproprietary_name": "Trypan Blue",
  "start_marketing_date": "20041216",
  "active_numerator_strength": ".3"
}

Related drugs

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