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United States · US · US:59390-218_22a50c28-e476-4966-b68c-065a4b8e157f

ALTAFLUOR

Orange BookUNIIATC D04AB

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

Identification

ManufacturerAltaire Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD04AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5939021805
    5 mL in 1 BOTTLE, DROPPER (59390-218-05)

Annotations

UNII (FDA Substance ID)
0VE4U49K15
BENOXINATE HYDROCHLORIDE
RxCUI 235398
Orange Book
N208582
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",
  "productid": "59390-218_22a50c28-e476-4966-b68c-065a4b8e157f",
  "productndc": "59390-218",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208582",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4%;0.25%",
        "product_no": "001",
        "approval_date": "Dec 14, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM",
  "proprietary_name": "ALTAFLUOR",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA208582",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluorescein Sodium and Benoxinate Hydrochloride",
  "start_marketing_date": "20180301",
  "active_numerator_strength": "4; 2.5"
}

Related drugs

Other records sharing ATC code D04AB.

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