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United States · US · US:24208-508_0cdbef52-3996-4d79-85ae-c5dd70ac93ed
Loteprednol Etabonate
Orange BookUNIISPLATC S01BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124208508011 BOTTLE in 1 CARTON (24208-508-01) / 5 g in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N202872
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YEH1EZ96K6",
"rxcui": "52177",
"inchikey": "DMKSVUSAATWOCU-HROMYWEYSA-N",
"display_name": "LOTEPREDNOL ETABONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"3c2e7083-6ba1-4131-a23f-462b02e5c036": {
"match": "brand_token",
"title": "LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "5",
"published_date": "2026-04-28"
}
},
"productid": "24208-508_0cdbef52-3996-4d79-85ae-c5dd70ac93ed",
"productndc": "24208-508",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "202872",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Sep 28, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOTEPREDNOL ETABONATE",
"proprietary_name": "Loteprednol Etabonate",
"active_ingred_unit": "mg/g",
"application_number": "NDA202872",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "loteprednol etabonate",
"start_marketing_date": "20210217",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01BA14.
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