Bromfenac Ophthalmic Solution 0.09%

Orange BookUNIISPLATC S01BC11

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeS01BC11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6233250817
1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

8ECV571Y37

BROMFENAC SODIUM

RxCUI 47364

Orange Book

A210560

AT2

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": "62332-508_824d37d0-e25f-4df8-be0e-d9a65046fc10",
  "productndc": "62332-508",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "210560",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT2",
        "strength": "EQ 0.09% ACID",
        "product_no": "001",
        "approval_date": "Jun 21, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BROMFENAC SODIUM",
  "proprietary_name": "Bromfenac Ophthalmic Solution 0.09%",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bromfenac Ophthalmic Solution 0.09%",
  "start_marketing_date": "20190621",
  "active_numerator_strength": "1.035"
}

Related drugs

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