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United States · US · US:11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b
FML
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
- ndc1111980211051 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1111980211101 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 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": {
"c9cbf06e-5413-4c3c-9ded-174c856a4ce1": {
"match": "brand_token",
"title": "FML (FLUOROMETHOLONE) SUSPENSION/ DROPS [SANDOZ INC]",
"spl_version": "1",
"published_date": "2026-03-31"
}
},
"productid": "11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b",
"productndc": "11980-211",
"dosage_form": "SUSPENSION/ 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": "FML",
"active_ingred_unit": "mg/mL",
"application_number": "NDA016851",
"marketing_category": "NDA",
"nonproprietary_name": "fluorometholone",
"start_marketing_date": "19720201",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01BA07.
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