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United States · US · US:11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9
FML FORTE
Orange BookUNIISPLATC S01BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS01BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1111980228051 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1111980228101 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
SV0CSG527L
FLUOROMETHOLONE
RxCUI 4491
Orange Book
N019216
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": "11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9",
"productndc": "11980-228",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "019216",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.25%",
"product_no": "001",
"approval_date": "Apr 23, 1986"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOROMETHOLONE",
"proprietary_name": "FML FORTE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019216",
"marketing_category": "NDA",
"nonproprietary_name": "fluorometholone",
"start_marketing_date": "19860501",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code S01BA07.
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