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United States · US · US:24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377f

Bepreve

Orange BookUNII

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420862901
    1 BOTTLE, DROPPER in 1 CARTON (24208-629-01) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420862902
    1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420862903
    1 BOTTLE, DROPPER in 1 CARTON (24208-629-03) / 1 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
6W18MO1QR3
BEPOTASTINE BESYLATE
RxCUI 658552
Orange Book
N022288
AT
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",
  "productid": "24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377f",
  "productndc": "24208-629",
  "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": "Bepreve",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022288",
  "marketing_category": "NDA",
  "nonproprietary_name": "bepotastine besilate",
  "start_marketing_date": "20090908",
  "active_numerator_strength": "15"
}

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