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United States · US · US:0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140
Bepotastine Besilate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103787055351 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER
- ndc1103787055671 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER
Annotations
Orange Book
A206220
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": "0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140",
"productndc": "0378-7055",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "206220",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "1.5%",
"product_no": "001",
"approval_date": "Mar 18, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BEPOTASTINE BESILATE",
"proprietary_name": "Bepotastine Besilate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206220",
"marketing_category": "ANDA",
"nonproprietary_name": "Bepotastine Besilate",
"start_marketing_date": "20210528",
"active_numerator_strength": "15"
}Access this data programmatically
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