bromfenac sodium

Generic: bromfenac sodium

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

Drug Facts

Product Profile

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

bromfenac sodium .805 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-433
Product ID 68180-433_bdba6fae-8155-4d11-a0ec-a68e3c934ff9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206027
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

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 68180433
Hyphenated Format 68180-433

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 sodium (source: ndc)
Generic Name bromfenac sodium (source: ndc)
Application Number ANDA206027 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .805 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68180-433-02 1 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.805 mg/mL)

Linked Drug Pages (1)

bromfenac sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "bdba6fae-8155-4d11-a0ec-a68e3c934ff9", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["26f3e5b3-a739-4b09-8046-e71ecb3a5a7b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68180-433-02)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "68180-433-02", "marketing_start_date": "20240108"}], "brand_name": "bromfenac sodium", "product_id": "68180-433_bdba6fae-8155-4d11-a0ec-a68e3c934ff9", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68180-433", "generic_name": "bromfenac sodium", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bromfenac sodium", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".805 mg/mL"}], "application_number": "ANDA206027", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}