timolol maleate

Generic: timolol maleate

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-045
Product ID 82260-045_261bb64e-88e2-1585-e063-6394a90aeaf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021516
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260045
Hyphenated Format 82260-045

Supplemental Identifiers

RxCUI
1992299
UNII
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 timolol maleate (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number NDA021516 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-045-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-045-25) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82260-045-05 1 BOTTLE, DROPPER in 1 CARTON (82260-045-05) / 5 mL in 1 BOTTLE, DROPPER 82260-045-25 1 BOTTLE, DROPPER in 1 CARTON (82260-045-25) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "261bb64e-88e2-1585-e063-6394a90aeaf4", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1992299"], "spl_set_id": ["b686bbad-1ef7-4b94-a316-4d182a40b89a"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-045-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-045-05", "marketing_start_date": "20220623"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-045-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-045-25", "marketing_start_date": "20220623"}], "brand_name": "Timolol Maleate", "product_id": "82260-045_261bb64e-88e2-1585-e063-6394a90aeaf4", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82260-045", "generic_name": "Timolol Maleate", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA021516", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}