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United States · US · US:82260-602_5114ef85-6052-bb94-e063-6294a90a1abc

bromfenac ophthalmic solution

Orange BookUNIISPLATC S01BC11

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

Identification

ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC codeS01BC11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8226060203
    1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
N203168
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8ECV571Y37",
    "rxcui": "47364",
    "inchikey": "PPOSVVJOVKVBPW-UHFFFAOYSA-L",
    "display_name": "BROMFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "fa249b9e-931c-454d-ba06-33139d5580e7": {
      "match": "brand_token",
      "title": "BROMFENAC OPHTHALMIC SOLUTION (BROMFENAC SODIUM) SOLUTION/ DROPS [DR. REDDY'S LABORATORIES INC.]",
      "spl_version": "4",
      "published_date": "2026-05-07"
    }
  },
  "productid": "82260-602_5114ef85-6052-bb94-e063-6294a90a1abc",
  "productndc": "82260-602",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "203168",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.07% ACID",
        "product_no": "001",
        "approval_date": "Apr 5, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BROMFENAC SODIUM",
  "proprietary_name": "bromfenac ophthalmic solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA203168",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Bromfenac Sodium",
  "start_marketing_date": "20240108",
  "active_numerator_strength": ".7"
}

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