bromfenac

Generic: bromfenac

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

Drug Facts

Product Profile

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

bromfenac sodium 1.035 mg/mL

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-649
Product ID 72485-649_08a05c09-5f0e-dca3-e063-6294a90a1bc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203395
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

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 72485649
Hyphenated Format 72485-649

Supplemental Identifiers

RxCUI
578018
UPC
0372485649716
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 ANDA203395 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1.035 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-649-71) / 1.7 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

72485-649-71 1 BOTTLE, DROPPER in 1 CARTON (72485-649-71) / 1.7 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (1.035 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": "08a05c09-5f0e-dca3-e063-6294a90a1bc1", "openfda": {"upc": ["0372485649716"], "unii": ["8ECV571Y37"], "rxcui": ["578018"], "spl_set_id": ["08a0591e-6cb3-30ce-e063-6394a90a33fb"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-649-71)  / 1.7 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-649-71", "marketing_start_date": "20231026"}], "brand_name": "Bromfenac", "product_id": "72485-649_08a05c09-5f0e-dca3-e063-6294a90a1bc1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72485-649", "generic_name": "Bromfenac", "labeler_name": "ARMAS PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": "1.035 mg/mL"}], "application_number": "ANDA203395", "marketing_category": "ANDA", "marketing_start_date": "20231026", "listing_expiration_date": "20261231"}