🇺🇸
United States · US · US:49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33
BROMSITE
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
- ndc1149708754411 POUCH in 1 CARTON (49708-754-41) / 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": {
"144a5072-341b-4591-8705-773b63044bcc": {
"match": "brand_token",
"title": "BROMSITE 0.075% (BROMFENAC) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "5",
"published_date": "2026-01-09"
}
},
"productid": "49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33",
"productndc": "49708-754",
"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": "BROMSITE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA206911",
"marketing_category": "NDA",
"nonproprietary_name": "bromfenac",
"start_marketing_date": "20160501",
"active_numerator_strength": ".76"
}Related drugs
Other records sharing ATC code S01BC11.
Access this data programmatically
Query BROMSITE 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.