brimonidine tartrate and timolol maleate

Generic: brimonidine tartrate and timolol maleate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate and timolol maleate
Generic Name brimonidine tartrate and timolol maleate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-652
Product ID 70069-652_c456714b-707d-4449-b114-de5329846b94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216114
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

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 70069652
Hyphenated Format 70069-652

Supplemental Identifiers

RxCUI
861635
UPC
0370069652015 0370069651018 0370069653012
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 and timolol maleate (source: ndc)
Generic Name brimonidine tartrate and timolol maleate (source: ndc)
Application Number ANDA216114 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-652-01 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Brimonidine Tartrate and Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c456714b-707d-4449-b114-de5329846b94", "openfda": {"upc": ["0370069652015", "0370069651018", "0370069653012"], "unii": ["P8Y54F701R", "4S9CL2DY2H"], "rxcui": ["861635"], "spl_set_id": ["e4fdbd17-73b7-49ed-9de3-591f36e0645d"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-652-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-652-01", "marketing_start_date": "20241010"}], "brand_name": "Brimonidine Tartrate and Timolol Maleate", "product_id": "70069-652_c456714b-707d-4449-b114-de5329846b94", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-652", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate and Timolol Maleate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA216114", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}