bromfenac sodium

Generic: bromfenac sodium

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac sodium
Generic Name bromfenac sodium
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .805 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-583
Product ID 46708-583_f66f1436-daaa-412a-8822-c64866cfeada
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214340
Listing Expiration 2026-12-31
Marketing Start 2024-07-08

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 46708583
Hyphenated Format 46708-583

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 ANDA214340 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .805 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-583-03 1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE

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": "f66f1436-daaa-412a-8822-c64866cfeada", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["f66f1436-daaa-412a-8822-c64866cfeada"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-583-03)  / 3 mL in 1 BOTTLE", "package_ndc": "46708-583-03", "marketing_start_date": "20240708"}], "brand_name": "BROMFENAC SODIUM", "product_id": "46708-583_f66f1436-daaa-412a-8822-c64866cfeada", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "46708-583", "generic_name": "BROMFENAC SODIUM", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BROMFENAC SODIUM", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".805 mg/mL"}], "application_number": "ANDA214340", "marketing_category": "ANDA", "marketing_start_date": "20240708", "listing_expiration_date": "20261231"}