Fluorescein

Orange BookUNIISPLATC S01JA51

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

Identification

ManufacturerNexus Pharmaceuticals LLC

CountryUS (United States)

ATC codeS01JA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1478912205
10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)

Annotations

UNII (FDA Substance ID)

TPY09G7XIR

FLUORESCEIN

RxCUI 25138

Orange Book

A215709

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "TPY09G7XIR",
    "rxcui": "25138",
    "inchikey": "GNBHRKFJIUUOQI-UHFFFAOYSA-N",
    "display_name": "FLUORESCEIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "770582e3-c99b-4a02-868c-29309013717e": {
      "match": "brand_token",
      "title": "FLUORESCEIN INJECTION, SOLUTION [BPI LABS LLC]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "14789-122_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2",
  "productndc": "14789-122",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215709",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/2ML (EQ 250MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUORESCEIN",
  "proprietary_name": "Fluorescein",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215709",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluorescein",
  "start_marketing_date": "20231024",
  "active_numerator_strength": "500"
}

Related drugs

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