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United States · US · US:82260-299_316eb8c8-48a7-a4b0-e063-6294a90a0bad
Loteprednol Etabonate
Orange BookUNIISPLATC S01BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC codeS01BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182260299051 BOTTLE in 1 CARTON (82260-299-05) / 5 mL in 1 BOTTLE
- ndc1182260299101 BOTTLE in 1 CARTON (82260-299-10) / 10 mL in 1 BOTTLE
- ndc1182260299151 BOTTLE in 1 CARTON (82260-299-15) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N020583
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": "82260-299_316eb8c8-48a7-a4b0-e063-6294a90a0bad",
"productndc": "82260-299",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "020583",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Mar 9, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOTEPREDNOL ETABONATE",
"proprietary_name": "Loteprednol Etabonate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020583",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "loteprednol etabonate",
"start_marketing_date": "20230407",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01BA14.
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