bromfenac

Generic: bromfenac

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac
Generic Name bromfenac
Labeler aurobindo pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .9 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-789
Product ID 65862-789_56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204813
Listing Expiration 2026-12-31
Marketing Start 2022-03-18

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 65862789
Hyphenated Format 65862-789

Supplemental Identifiers

RxCUI
578018
UPC
0365862789174
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 ANDA204813 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .9 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-789-17) / 1.7 mL in 1 BOTTLE
source: ndc

Packages (1)

65862-789-17 1 BOTTLE in 1 CARTON (65862-789-17) / 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": "56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1", "openfda": {"upc": ["0365862789174"], "unii": ["8ECV571Y37"], "rxcui": ["578018"], "spl_set_id": ["fa40fc6b-1bd0-4496-b53a-8b3e1c122a50"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-789-17)  / 1.7 mL in 1 BOTTLE", "package_ndc": "65862-789-17", "marketing_start_date": "20220318"}], "brand_name": "Bromfenac", "product_id": "65862-789_56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65862-789", "generic_name": "Bromfenac", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".9 mg/mL"}], "application_number": "ANDA204813", "marketing_category": "ANDA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}