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United States · US · US:82260-466_483360bc-332c-6ccd-e063-6394a90a0b25

Besivance

Orange BookUNIISPLATC S01AE08

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

Identification

ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC codeS01AE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8226046605
    1 BOTTLE, DROPPER in 1 CARTON (82260-466-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
BFE2NBZ7NX
BESIFLOXACIN
RxCUI 819911
Orange Book
N022308
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BFE2NBZ7NX",
    "rxcui": "819911",
    "inchikey": "QFFGVLORLPOAEC-SNVBAGLBSA-N",
    "display_name": "BESIFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "ff971287-5610-4f15-8392-fc974e6ff646": {
      "match": "brand_token",
      "title": "BESIVANCE (BESIFLOXACIN) SUSPENSION [BAUSCH & LOMB AMERICAS INC.]",
      "spl_version": "1",
      "published_date": "2026-01-13"
    }
  },
  "productid": "82260-466_483360bc-332c-6ccd-e063-6394a90a0b25",
  "productndc": "82260-466",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "022308",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.6% BASE",
        "product_no": "001",
        "approval_date": "May 28, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BESIFLOXACIN",
  "proprietary_name": "Besivance",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022308",
  "marketing_category": "NDA",
  "nonproprietary_name": "Besifloxacin",
  "start_marketing_date": "20260109",
  "active_numerator_strength": "6"
}

Related drugs

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