TISSUEBLUE

Orange BookUNIISPL

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

Identification

ManufacturerD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6880372205
10 POUCH in 1 CARTON (68803-722-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

M1ZRX790SI

BRILLIANT BLUE G

RxCUI 1998867

Orange Book

N209569

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M1ZRX790SI",
    "rxcui": "1998867",
    "inchikey": "RWVGQQGBQSJDQV-UHFFFAOYSA-M",
    "display_name": "BRILLIANT BLUE G",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAOCULAR; OPHTHALMIC",
  "spl_meta": {
    "9d4b28b4-c582-4e2c-abd9-f7e203378e2d": {
      "match": "brand_token",
      "title": "TISSUEBLUE (BRILLIANT BLUE G) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.]",
      "spl_version": "8",
      "published_date": "2026-04-20"
    }
  },
  "productid": "68803-722_4fa75b7a-9ebf-72e1-e063-6294a90a2565",
  "productndc": "68803-722",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209569",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.025%",
        "product_no": "001",
        "approval_date": "Dec 20, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRILLIANT BLUE G",
  "proprietary_name": "TISSUEBLUE",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA209569",
  "marketing_category": "NDA",
  "nonproprietary_name": "Brilliant Blue G",
  "start_marketing_date": "20191231",
  "active_numerator_strength": ".0125"
}

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