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United States · US · US:0781-6187_4d324ee9-c00e-27ba-e063-6294a90a049c
FML
Orange BookUNIISPLATC S01BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107816187701 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPER
- ndc1107816187751 BOTTLE, DROPPER in 1 CARTON (0781-6187-75) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
SV0CSG527L
FLUOROMETHOLONE
RxCUI 4491
Orange Book
A218819
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": {
"c9cbf06e-5413-4c3c-9ded-174c856a4ce1": {
"match": "brand_token",
"title": "FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [SANDOZ INC]",
"spl_version": "1",
"published_date": "2026-03-31"
}
},
"productid": "0781-6187_4d324ee9-c00e-27ba-e063-6294a90a049c",
"productndc": "0781-6187",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "218819",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Feb 12, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROMETHOLONE",
"proprietary_name": "FML",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218819",
"marketing_category": "ANDA",
"nonproprietary_name": "fluorometholone",
"start_marketing_date": "20260330",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01BA07.
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