brimonidine tartrate and timolol maleate

Generic: brimonidine tartrate, timolol maleate

Labeler: pacific pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate and timolol maleate
Generic Name brimonidine tartrate, timolol maleate
Labeler pacific pharma, inc.
Dosage Form SOLUTION/ DROPS
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Pacific Pharma, Inc.

Identifiers & Regulatory

Product NDC 82182-455
Product ID 82182-455_4df1c7ca-8b16-47fe-a743-c12ca4af5e07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021398
Listing Expiration 2026-12-31
Marketing Start 2022-10-21

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 82182455
Hyphenated Format 82182-455

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 and timolol maleate (source: ndc)
Generic Name brimonidine tartrate, timolol maleate (source: ndc)
Application Number NDA021398 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (82182-455-05)
  • 10 mL in 1 BOTTLE, PLASTIC (82182-455-10)
  • 15 mL in 1 BOTTLE, PLASTIC (82182-455-15)
source: ndc

Packages (3)

82182-455-05 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) 82182-455-10 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) 82182-455-15 15 mL in 1 BOTTLE, PLASTIC (82182-455-15)

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": ["TOPICAL"], "spl_id": "4df1c7ca-8b16-47fe-a743-c12ca4af5e07", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["8b13bd5a-b65f-4e39-83f1-8d3abe97d4c0"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (82182-455-05)", "package_ndc": "82182-455-05", "marketing_start_date": "20221021"}, {"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (82182-455-10)", "package_ndc": "82182-455-10", "marketing_start_date": "20221021"}, {"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (82182-455-15)", "package_ndc": "82182-455-15", "marketing_start_date": "20221021"}], "brand_name": "BRIMONIDINE TARTRATE and TIMOLOL MALEATE", "product_id": "82182-455_4df1c7ca-8b16-47fe-a743-c12ca4af5e07", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82182-455", "generic_name": "BRIMONIDINE TARTRATE, TIMOLOL MALEATE", "labeler_name": "Pacific Pharma, Inc.", "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": "NDA021398", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20221021", "listing_expiration_date": "20261231"}