bromfenac

Generic: bromfenac

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac
Generic Name bromfenac
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .7 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1526
Product ID 60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210962
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

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 602191526
Hyphenated Format 60219-1526

Supplemental Identifiers

RxCUI
1375917
UPC
0360219152632
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 ANDA210962 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .7 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60219-1526-3 1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.7 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": "ba099985-d2c6-4a78-838f-9f2ae98f792a", "openfda": {"upc": ["0360219152632"], "unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["2c4eba0d-db55-4b54-a2ad-dfef1da9462f"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "60219-1526-3", "marketing_start_date": "20240731"}], "brand_name": "Bromfenac", "product_id": "60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60219-1526", "generic_name": "Bromfenac", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".7 mg/mL"}], "application_number": "ANDA210962", "marketing_category": "ANDA", "marketing_start_date": "20240731", "listing_expiration_date": "20261231"}