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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
- ndc1160758880051 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1160758880101 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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