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United States · US · US:60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38

FLUOROMETHOLONE

Orange BookUNIISPLATC S01BA07

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

Identification

ManufacturerPacific Pharma, Inc.
CountryUS (United States)
ATC codeS01BA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6075888005
    1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    6075888010
    1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
SV0CSG527L
FLUOROMETHOLONE
RxCUI 4491
Orange Book
N016851
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SV0CSG527L",
    "rxcui": "4491",
    "inchikey": "FAOZLTXFLGPHNG-KNAQIMQKSA-N",
    "display_name": "FLUOROMETHOLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "af59c420-789d-4c05-b3fc-c3f855bcac24": {
      "match": "brand_token",
      "title": "FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]",
      "spl_version": "10",
      "published_date": "2025-12-19"
    }
  },
  "productid": "60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38",
  "productndc": "60758-880",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "016851",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "002",
        "approval_date": "Jul 28, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROMETHOLONE",
  "proprietary_name": "FLUOROMETHOLONE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA016851",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "fluorometholone",
  "start_marketing_date": "19971031",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code S01BA07.

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