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United States · US · US:82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5
Flarex
Orange BookUNIISPLATC S01BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeS01BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182667010001 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC
- ndc1182667010011 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
9I50C3I3OK
FLUOROMETHOLONE ACETATE
RxCUI 221101
Orange Book
N019079
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9I50C3I3OK",
"rxcui": "221101",
"inchikey": "YRFXGQHBPBMFHW-SBTZIJSASA-N",
"display_name": "FLUOROMETHOLONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"f060dec4-09dc-4266-ab4c-a6ed49cd8126": {
"match": "brand_token",
"title": "FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [HARROW EYE, LLC]",
"spl_version": "2",
"published_date": "2025-04-03"
}
},
"productid": "82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5",
"productndc": "82667-010",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "019079",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.1%",
"product_no": "001",
"approval_date": "Feb 11, 1986"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROMETHOLONE ACETATE",
"proprietary_name": "Flarex",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019079",
"marketing_category": "NDA",
"nonproprietary_name": "fluorometholone acetate",
"start_marketing_date": "20250331",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01BA07.
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