FLUORESCEIN

Orange BookUNIISPLATC S01JA51

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeS01JA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166215333
12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

93X55PE38X

FLUORESCEIN SODIUM

RxCUI 57789

Orange Book

N022186

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": "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": "51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92",
  "productndc": "51662-1533",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022186",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Aug 8, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/2ML (EQ 250MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Aug 8, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUORESCEIN SODIUM",
  "proprietary_name": "FLUORESCEIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022186",
  "marketing_category": "NDA",
  "nonproprietary_name": "FLUORESCEIN",
  "start_marketing_date": "20210510",
  "active_numerator_strength": "100"
}

Related drugs

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