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United States · US · US:60219-1366_867b7a8d-85c2-4b5c-8391-49d0a69cb97b
loteprednol etabonate
Orange BookUNIISPLATC S01BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeS01BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219136631 BOTTLE in 1 CARTON (60219-1366-3) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A216345
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": "60219-1366_867b7a8d-85c2-4b5c-8391-49d0a69cb97b",
"productndc": "60219-1366",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "216345",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%",
"product_no": "001",
"approval_date": "Dec 13, 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": "ANDA216345",
"marketing_category": "ANDA",
"nonproprietary_name": "loteprednol etabonate",
"start_marketing_date": "20241218",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code S01BA14.
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