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United States · US · US:68180-433_bdba6fae-8155-4d11-a0ec-a68e3c934ff9
bromfenac sodium
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180433021 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
A206027
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": "68180-433_bdba6fae-8155-4d11-a0ec-a68e3c934ff9",
"productndc": "68180-433",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "206027",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.07% ACID",
"product_no": "001",
"approval_date": "Nov 22, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMFENAC SODIUM",
"proprietary_name": "bromfenac sodium",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206027",
"marketing_category": "ANDA",
"nonproprietary_name": "bromfenac sodium",
"start_marketing_date": "20240108",
"active_numerator_strength": ".805"
}Related drugs
Other records sharing ATC code S01BC11.
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