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United States · US · US:60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23
fluorometholone ophthalmic suspension
Orange BookUNIISPLATC S01BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeS01BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219158531 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
SV0CSG527L
FLUOROMETHOLONE
RxCUI 4491
Orange Book
A216348
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": "60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23",
"productndc": "60219-1585",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "216348",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Jan 9, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROMETHOLONE",
"proprietary_name": "fluorometholone ophthalmic suspension",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216348",
"marketing_category": "ANDA",
"nonproprietary_name": "fluorometholone",
"start_marketing_date": "20230109",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01BA07.
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