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United States · US · US:24208-602_5114fa15-9db8-23b9-e063-6294a90ad057
Prolensa
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1124208602031 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER
- ndc1124208602041 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER
- ndc1124208602061 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 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": {
"4e072537-f73c-4a96-a65f-e2805ce112d8": {
"match": "brand_token",
"title": "PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]",
"spl_version": "19",
"published_date": "2026-05-07"
}
},
"productid": "24208-602_5114fa15-9db8-23b9-e063-6294a90ad057",
"productndc": "24208-602",
"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": "Prolensa",
"active_ingred_unit": "mg/mL",
"application_number": "NDA203168",
"marketing_category": "NDA",
"nonproprietary_name": "Bromfenac Sodium",
"start_marketing_date": "20130405",
"active_numerator_strength": ".7"
}Related drugs
Other records sharing ATC code S01BC11.
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