bromfenac

Generic: bromfenac

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac
Generic Name bromfenac
Labeler lupin pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .9 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-436
Product ID 68180-436_8df89f04-52dd-4d9c-8cf3-9c045e669463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202903
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

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 68180436
Hyphenated Format 68180-436

Supplemental Identifiers

RxCUI
578018
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 (source: ndc)
Generic Name bromfenac (source: ndc)
Application Number ANDA202903 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .9 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68180-436-01) / 1.7 mL in 1 BOTTLE
source: ndc

Packages (1)

68180-436-01 1 BOTTLE in 1 CARTON (68180-436-01) / 1.7 mL in 1 BOTTLE

Ingredients (1)

bromfenac sodium (.9 mg/mL)

Linked Drug Pages (1)

Bromfenac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8df89f04-52dd-4d9c-8cf3-9c045e669463", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["578018"], "spl_set_id": ["2fc689b7-d5ba-4591-8c23-b48e588d7a28"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-436-01)  / 1.7 mL in 1 BOTTLE", "package_ndc": "68180-436-01", "marketing_start_date": "20240202"}], "brand_name": "Bromfenac", "product_id": "68180-436_8df89f04-52dd-4d9c-8cf3-9c045e669463", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68180-436", "generic_name": "Bromfenac", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".9 mg/mL"}], "application_number": "ANDA202903", "marketing_category": "ANDA", "marketing_start_date": "20240202", "listing_expiration_date": "20261231"}