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United States · US · US:60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792a
Bromfenac
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219152631 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
A210962
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": "60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792a",
"productndc": "60219-1526",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "210962",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.07% ACID",
"product_no": "001",
"approval_date": "Jul 29, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMFENAC SODIUM",
"proprietary_name": "Bromfenac",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210962",
"marketing_category": "ANDA",
"nonproprietary_name": "Bromfenac",
"start_marketing_date": "20240731",
"active_numerator_strength": ".7"
}Related drugs
Other records sharing ATC code S01BC11.
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