Bepotastine Besilate

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006971101
1 BOTTLE in 1 CARTON (70069-711-01) / 5 mL in 1 BOTTLE

Annotations

Orange Book

A217770

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": "70069-711_32be8aa1-ad8e-4840-8d22-49316257cda4",
  "productndc": "70069-711",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217770",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1.5%",
        "product_no": "001",
        "approval_date": "Aug 14, 2024"
      }
    ],
    "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": "ANDA217770",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bepotastine Besilate",
  "start_marketing_date": "20241010",
  "active_numerator_strength": "15"
}

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