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United States · US · US:0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a
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 · 3
- ndc1105744135051 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1105744135101 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1105744135151 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A215204
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": "0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a",
"productndc": "0574-4135",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "215204",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Jan 29, 2025"
}
],
"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": "ANDA215204",
"marketing_category": "ANDA",
"nonproprietary_name": "loteprednol etabonate",
"start_marketing_date": "20260112",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01BA14.
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