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United States · US · US:0574-4080_08241818-e7df-4834-87c4-816c99d240de
LOTEPREDNOL ETABONATE
Orange BookUNIISPLATC S01BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeS01BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105744080051 BOTTLE, DROPPER in 1 CARTON (0574-4080-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1105744080101 BOTTLE, DROPPER in 1 CARTON (0574-4080-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A215203
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": "0574-4080_08241818-e7df-4834-87c4-816c99d240de",
"productndc": "0574-4080",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "215203",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%",
"product_no": "001",
"approval_date": "Jul 10, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOTEPREDNOL ETABONATE",
"proprietary_name": "LOTEPREDNOL ETABONATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215203",
"marketing_category": "ANDA",
"nonproprietary_name": "loteprednol etabonate",
"start_marketing_date": "20260331",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code S01BA14.
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