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United States · US · US:82260-630_202287f2-01bc-1d43-e063-6294a90a8da1
Bepotastine Besilate
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182260630051 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1182260630101 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
6W18MO1QR3
BEPOTASTINE BESYLATE
RxCUI 658552
Orange Book
N022288
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6W18MO1QR3",
"rxcui": "658552",
"inchikey": "UDGHXQPQKQPSBB-BOXHHOBZSA-N",
"display_name": "BEPOTASTINE BESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"75178670-aa57-45f9-94d5-efcf8305e683": {
"match": "brand_token",
"title": "BEPOTASTINE BESILATE SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "4",
"published_date": "2025-11-17"
}
},
"productid": "82260-630_202287f2-01bc-1d43-e063-6294a90a8da1",
"productndc": "82260-630",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "022288",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "1.5%",
"product_no": "001",
"approval_date": "Sep 8, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BEPOTASTINE BESYLATE",
"proprietary_name": "Bepotastine Besilate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022288",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "bepotastine besilate",
"start_marketing_date": "20210528",
"active_numerator_strength": "15"
}Access this data programmatically
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