🇺🇸
United States · US · US:46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918
Loteprednol etabonate and Tobramycin
Orange BookUNIISPLATC J01GB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ01GB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1146708801051 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE
- ndc1146708801101 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A217597
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": "46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918",
"productndc": "46708-801",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "217597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5%;0.3%",
"product_no": "001",
"approval_date": "Dec 10, 2025"
}
],
"appl_type": "A"
},
"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": "ANDA217597",
"marketing_category": "ANDA",
"nonproprietary_name": "Loteprednol etabonate and Tobramycin",
"start_marketing_date": "20251210",
"active_numerator_strength": "5; 3"
}Related drugs
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- GBNetildex 3mg/ml / 1mg/ml eye drops 0.3ml unit doseNordic Pharma Ltd
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- 🇺🇸ZyletBausch & Lomb Incorporated
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