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United States · US · US:24208-734_34f4eb14-b40e-1d6d-e063-6394a90a3e3b

Fluorescein Sodium and Benoxinate Hydrochloride

Orange BookUNIISPLATC D04AB

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeD04AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2420873405
    1 BOTTLE, GLASS in 1 CARTON (24208-734-05) / 5 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
0VE4U49K15
BENOXINATE HYDROCHLORIDE
RxCUI 235398
Orange Book
N211039
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0VE4U49K15",
    "rxcui": "235398",
    "inchikey": "PRGUDWLMFLCODA-UHFFFAOYSA-N",
    "display_name": "BENOXINATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "24208-734_34f4eb14-b40e-1d6d-e063-6394a90a3e3b",
  "productndc": "24208-734",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "211039",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4%;0.3%",
        "product_no": "001",
        "approval_date": "Mar 9, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM",
  "proprietary_name": "Fluorescein Sodium and Benoxinate Hydrochloride",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA211039",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluorescein Sodium and Benoxinate Hydrochloride",
  "start_marketing_date": "20200320",
  "active_numerator_strength": "4.4; 2.6"
}

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