Back to search
🇺🇸

United States · US · US:75907-093_51157bb8-5ca6-19cd-e063-6294a90a839d

bromfenac ophthalmic solution

Orange BookUNIISPLATC S01BC11

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeS01BC11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7590709303
    1 BOTTLE, DROPPER in 1 CARTON (75907-093-03) / 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": "75907-093_51157bb8-5ca6-19cd-e063-6294a90a839d",
  "productndc": "75907-093",
  "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": "20240715",
  "active_numerator_strength": ".7"
}

Related drugs

Other records sharing ATC code S01BC11.

Access this data programmatically

Query bromfenac ophthalmic solution and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.