brimonidine tartrate/timolol maleate ophthalmic solution

Generic: brimonidine tartrate and timolol maleate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate/timolol maleate ophthalmic solution
Generic Name brimonidine tartrate and timolol maleate
Labeler apotex corp.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 2 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0589
Product ID 60505-0589_1b350584-a1be-e9a4-9c25-00ec1a8ee4b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091442
Listing Expiration 2026-12-31
Marketing Start 2022-10-19

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-antagonists [moa] alpha-adrenergic agonist [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050589
Hyphenated Format 60505-0589

Supplemental Identifiers

RxCUI
861635
UNII
4S9CL2DY2H P8Y54F701R

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 brimonidine tartrate/timolol maleate ophthalmic solution (source: ndc)
Generic Name brimonidine tartrate and timolol maleate (source: ndc)
Application Number ANDA091442 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

60505-0589-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER 60505-0589-2 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER 60505-0589-3 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

brimonidine tartrate (2 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1b350584-a1be-e9a4-9c25-00ec1a8ee4b7", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["268c3f6b-8798-7987-3b8c-7b7f560af5d7"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0589-1", "marketing_start_date": "20221019"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0589-2", "marketing_start_date": "20221019"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0589-3", "marketing_start_date": "20221019"}], "brand_name": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution", "product_id": "60505-0589_1b350584-a1be-e9a4-9c25-00ec1a8ee4b7", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "60505-0589", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA091442", "marketing_category": "ANDA", "marketing_start_date": "20221019", "listing_expiration_date": "20261231"}