bromfenac ophthalmic solution 0.09%

Generic: bromfenac ophthalmic solution 0.09%

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

Drug Facts

Product Profile

Brand Name bromfenac ophthalmic solution 0.09%
Generic Name bromfenac ophthalmic solution 0.09%
Labeler alembic pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium 1.035 mg/mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-508
Product ID 62332-508_824d37d0-e25f-4df8-be0e-d9a65046fc10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210560
Listing Expiration 2026-12-31
Marketing Start 2019-06-21

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 62332508
Hyphenated Format 62332-508

Supplemental Identifiers

RxCUI
578018
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 ophthalmic solution 0.09% (source: ndc)
Generic Name bromfenac ophthalmic solution 0.09% (source: ndc)
Application Number ANDA210560 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1.035 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE
source: ndc

Packages (1)

62332-508-17 1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE

Ingredients (1)

bromfenac sodium (1.035 mg/mL)

Linked Drug Pages (1)

Bromfenac Ophthalmic Solution 0.09% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "824d37d0-e25f-4df8-be0e-d9a65046fc10", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["578018"], "spl_set_id": ["225070ee-d862-4d41-84b8-5bd7a8a03fd7"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62332-508-17)  / 1.7 mL in 1 BOTTLE", "package_ndc": "62332-508-17", "marketing_start_date": "20190621"}], "brand_name": "Bromfenac Ophthalmic Solution 0.09%", "product_id": "62332-508_824d37d0-e25f-4df8-be0e-d9a65046fc10", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62332-508", "generic_name": "Bromfenac Ophthalmic Solution 0.09%", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromfenac Ophthalmic Solution 0.09%", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": "1.035 mg/mL"}], "application_number": "ANDA210560", "marketing_category": "ANDA", "marketing_start_date": "20190621", "listing_expiration_date": "20261231"}