🇺🇸
United States · US · US:82260-358_48d4400d-e246-f109-e063-6394a90a8103
Loteprednol etabonate and tobramycin
Orange BookUNIISPLATC J01GB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC codeJ01GB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182260358051 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1182260358101 BOTTLE, DROPPER in 1 CARTON (82260-358-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N050804
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": "82260-358_48d4400d-e246-f109-e063-6394a90a8103",
"productndc": "82260-358",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "050804",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.5%;0.3%",
"product_no": "001",
"approval_date": "Dec 14, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOTEPREDNOL ETABONATE; TOBRAMYCIN",
"proprietary_name": "Loteprednol etabonate and tobramycin",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA050804",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "loteprednol etabonate and tobramycin",
"start_marketing_date": "20260109",
"active_numerator_strength": "5; 3"
}Related drugs
Other records sharing ATC code J01GB.
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- 🇺🇸Loteprednol etabonate and TobramycinAlembic Pharmaceuticals Limited
- GBNetildex 3mg/ml / 1mg/ml eye dropsNordic Pharma Ltd
- GBNetildex 3mg/ml / 1mg/ml eye drops 0.3ml unit doseNordic Pharma Ltd
- GBNetildex 3mg/ml / 1mg/ml eye gel 0.4ml unit doseNordic Pharma Ltd
- 🇺🇸ZyletBausch & Lomb Incorporated
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