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United States · US · US:46708-598_de111d74-c740-47b3-adc7-4b855df2c561
Bepotastine Besilate Ophthalmic Solution 1.5%
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1146708598051 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE
- ndc1146708598101 BOTTLE in 1 CARTON (46708-598-10) / 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": "46708-598_de111d74-c740-47b3-adc7-4b855df2c561",
"productndc": "46708-598",
"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
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