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United States · US · US:49708-755_47dae14d-3f32-0889-e063-6294a90aa707
bromfenac
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149708755411 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
N206911
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": "49708-755_47dae14d-3f32-0889-e063-6294a90aa707",
"productndc": "49708-755",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "206911",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.075% ACID",
"product_no": "001",
"approval_date": "Apr 8, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMFENAC SODIUM",
"proprietary_name": "bromfenac",
"active_ingred_unit": "mg/mL",
"application_number": "NDA206911",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "bromfenac",
"start_marketing_date": "20240207",
"active_numerator_strength": ".76"
}Related drugs
Other records sharing ATC code S01BC11.
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