🇺🇸
United States · US · US:72485-665_08a09440-b505-b2c9-e063-6394a90a0d76
Loteprednol Etabonate
Orange BookUNIISPLATC S01BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerARMAS PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeS01BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1172485665051 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1172485665101 BOTTLE, DROPPER in 1 CARTON (72485-665-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1172485665151 BOTTLE, DROPPER in 1 CARTON (72485-665-15) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A207609
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": "72485-665_08a09440-b505-b2c9-e063-6394a90a0d76",
"productndc": "72485-665",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "207609",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Apr 17, 2019"
}
],
"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": "ANDA207609",
"marketing_category": "ANDA",
"nonproprietary_name": "Loteprednol Etabonate",
"start_marketing_date": "20231026",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01BA14.
Access this data programmatically
Query Loteprednol Etabonate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.