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United States · US · US:81298-8660_ceefeb58-5c89-4157-a0bc-8a1409dc3873

AK-FLUOR

Orange BookUNIISPLATC S01JA51

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

Identification

ManufacturerLong Grove Pharmaceuticals, LLC
CountryUS (United States)
ATC codeS01JA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8129886603
    12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)

Annotations

UNII (FDA Substance ID)
93X55PE38X
FLUORESCEIN SODIUM
RxCUI 57789
Orange Book
N022186
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": "INTRAVENOUS",
  "spl_meta": {
    "73511e79-c050-4dc0-aa2f-a79ed320b5b0": {
      "match": "brand_token",
      "title": "AK-FLUOR (FLUORESCEIN) INJECTION [LONG GROVE PHARMACEUTICALS, LLC]",
      "spl_version": "4",
      "published_date": "2026-03-25"
    }
  },
  "productid": "81298-8660_ceefeb58-5c89-4157-a0bc-8a1409dc3873",
  "productndc": "81298-8660",
  "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": "AK-FLUOR",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022186",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluorescein",
  "start_marketing_date": "20240928",
  "active_numerator_strength": "100"
}

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