bromfenac ophthalmic solution, 0.07%

Generic: bromfenac sodium

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac ophthalmic solution, 0.07%
Generic Name bromfenac sodium
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .7 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-1006
Product ID 60505-1006_f729e800-0b53-25a7-f7dc-bee3bdf29882
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207334
Listing Expiration 2026-12-31
Marketing Start 2024-07-11

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605051006
Hyphenated Format 60505-1006

Supplemental Identifiers

RxCUI
1375917
UNII
8ECV571Y37

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bromfenac ophthalmic solution, 0.07% (source: ndc)
Generic Name bromfenac sodium (source: ndc)
Application Number ANDA207334 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .7 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60505-1006-1 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER 60505-1006-2 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.7 mg/mL)

Linked Drug Pages (1)

Bromfenac Ophthalmic Solution, 0.07% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "f729e800-0b53-25a7-f7dc-bee3bdf29882", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["4246c669-3c2a-2a2b-3b1c-696deb4ab519"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1)  / 1.6 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-1006-1", "marketing_start_date": "20240711"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-1006-2", "marketing_start_date": "20240711"}], "brand_name": "Bromfenac Ophthalmic Solution, 0.07%", "product_id": "60505-1006_f729e800-0b53-25a7-f7dc-bee3bdf29882", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60505-1006", "generic_name": "Bromfenac Sodium", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac Ophthalmic Solution, 0.07%", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".7 mg/mL"}], "application_number": "ANDA207334", "marketing_category": "ANDA", "marketing_start_date": "20240711", "listing_expiration_date": "20261231"}