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United States · US · US:60505-1006_f729e800-0b53-25a7-f7dc-bee3bdf29882
Bromfenac Ophthalmic Solution, 0.07%
Orange BookUNIISPLATC S01BC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeS01BC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1160505100611 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER
- ndc1160505100621 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
8ECV571Y37
BROMFENAC SODIUM
RxCUI 47364
Orange Book
A207334
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": "60505-1006_f729e800-0b53-25a7-f7dc-bee3bdf29882",
"productndc": "60505-1006",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "207334",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.07% ACID",
"product_no": "001",
"approval_date": "Jul 8, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BROMFENAC SODIUM",
"proprietary_name": "Bromfenac Ophthalmic Solution, 0.07%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207334",
"marketing_category": "ANDA",
"nonproprietary_name": "Bromfenac Sodium",
"start_marketing_date": "20240711",
"active_numerator_strength": ".7"
}Related drugs
Other records sharing ATC code S01BC11.
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