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United States · US · US:0065-0092_85861756-9727-4a43-8a4e-48564e341c48

FLUORESCITE

Orange BookUNIISPLATC S01JA51

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

Identification

ManufacturerAlcon, Inc.
CountryUS (United States)
ATC codeS01JA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0065009265
    12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
93X55PE38X
FLUORESCEIN SODIUM
RxCUI 57789
Orange Book
N021980
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "93X55PE38X",
    "rxcui": "57789",
    "inchikey": "NJDNXYGOVLYJHP-UHFFFAOYSA-L",
    "display_name": "FLUORESCEIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9": {
      "match": "brand_token",
      "title": "FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.]",
      "spl_version": "18",
      "published_date": "2023-12-15"
    }
  },
  "productid": "0065-0092_85861756-9727-4a43-8a4e-48564e341c48",
  "productndc": "0065-0092",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021980",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Mar 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUORESCEIN SODIUM",
  "proprietary_name": "FLUORESCITE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021980",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluorescein sodium",
  "start_marketing_date": "19720915",
  "active_numerator_strength": "100"
}

Related drugs

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