brimonidine tartrate/timolol maleate ophthalmic solution (69315-330)

Drug Facts

Product Profile

Brand Name brimonidine tartrate/timolol maleate ophthalmic solution

Generic Name brimonidine tartrate and timolol maleate

Labeler leading pharma, llc

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

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

Manufacturer

Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-330

Product ID 69315-330_16b451fa-d16e-4138-a5b9-e4424e56920b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA219093

Listing Expiration 2026-12-31

Marketing Start 2025-05-29

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 69315330

Hyphenated Format 69315-330

Supplemental Identifiers

RxCUI

861635

UPC

0369315330050 0369315330104 0369315330159

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 ANDA219093 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

2 mg/mL
5 mg/mL

source: ndc

Packaging

1 BOTTLE, DROPPER in 1 CARTON (69315-330-05) / 5 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (69315-330-10) / 10 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (69315-330-15) / 15 mL in 1 BOTTLE, DROPPER

source: ndc

Packages (3)

69315-330-05 1 BOTTLE, DROPPER in 1 CARTON (69315-330-05) / 5 mL in 1 BOTTLE, DROPPER 69315-330-10 1 BOTTLE, DROPPER in 1 CARTON (69315-330-10) / 10 mL in 1 BOTTLE, DROPPER 69315-330-15 1 BOTTLE, DROPPER in 1 CARTON (69315-330-15) / 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": "16b451fa-d16e-4138-a5b9-e4424e56920b", "openfda": {"upc": ["0369315330050", "0369315330104", "0369315330159"], "unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["533f9979-0cd7-485c-8c50-abbf717c5031"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-330-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-330-05", "marketing_start_date": "20250529"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-330-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-330-10", "marketing_start_date": "20250529"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-330-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-330-15", "marketing_start_date": "20250529"}], "brand_name": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution", "product_id": "69315-330_16b451fa-d16e-4138-a5b9-e4424e56920b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "69315-330", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Leading Pharma, LLC", "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": "ANDA219093", "marketing_category": "ANDA", "marketing_start_date": "20250529", "listing_expiration_date": "20261231"}