🇺🇸
United States · US · US:62332-598_ce72ab26-85a1-4fb5-a605-80bebe22f929
Bepotastine Besilate Ophthalmic Solution 1.5%
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1162332598051 BOTTLE in 1 CARTON (62332-598-05) / 5 mL in 1 BOTTLE
- ndc1162332598101 BOTTLE in 1 CARTON (62332-598-10) / 10 mL in 1 BOTTLE
Annotations
Orange Book
A214588
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "62332-598_ce72ab26-85a1-4fb5-a605-80bebe22f929",
"productndc": "62332-598",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "214588",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "1.5%",
"product_no": "001",
"approval_date": "Apr 5, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BEPOTASTINE BESILATE",
"proprietary_name": "Bepotastine Besilate Ophthalmic Solution 1.5%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214588",
"marketing_category": "ANDA",
"nonproprietary_name": "Bepotastine Besilate Ophthalmic Solution 1.5%",
"start_marketing_date": "20230405",
"active_numerator_strength": "15"
}Access this data programmatically
Query Bepotastine Besilate Ophthalmic Solution 1.5% 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.