brimonidine tartrate/timolol maleate ophthalmic solution

Generic: brimonidine tartrate and timolol maleate

Labeler: caplin steriles limited
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 caplin steriles limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-164
Product ID 65145-164_eac3cec2-b373-4936-89f0-c6d300e09f6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219093
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

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 65145164
Hyphenated Format 65145-164

Supplemental Identifiers

RxCUI
861635
UPC
0365145162014 0365145163011 0365145164018
UNII
P8Y54F701R 4S9CL2DY2H

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 (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

65145-164-01 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 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": "eac3cec2-b373-4936-89f0-c6d300e09f6e", "openfda": {"upc": ["0365145162014", "0365145163011", "0365145164018"], "unii": ["P8Y54F701R", "4S9CL2DY2H"], "rxcui": ["861635"], "spl_set_id": ["eac3cec2-b373-4936-89f0-c6d300e09f6e"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (65145-164-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "65145-164-01", "marketing_start_date": "20250310"}], "brand_name": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution", "product_id": "65145-164_eac3cec2-b373-4936-89f0-c6d300e09f6e", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "65145-164", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Caplin Steriles Limited", "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": "20250310", "listing_expiration_date": "20261231"}