timoptic-xe

Generic: timolol maleate

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name timoptic-xe
Generic Name timolol maleate
Labeler bausch & lomb incorporated
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-816
Product ID 24208-816_cb6890c5-7788-453b-910d-10c2bee17d04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020330
Listing Expiration 2026-12-31
Marketing Start 2016-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208816
Hyphenated Format 24208-816

Supplemental Identifiers

RxCUI
313407 313408 861420 861422
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 timoptic-xe (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number NDA020330 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

24208-816-05 1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Timoptic-XE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "cb6890c5-7788-453b-910d-10c2bee17d04", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313407", "313408", "861420", "861422"], "spl_set_id": ["a4d03de7-06b7-4cfc-9d1b-616969df209c"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05)  / 5 mL in 1 BOTTLE, DISPENSING", "package_ndc": "24208-816-05", "marketing_start_date": "20160531"}], "brand_name": "Timoptic-XE", "product_id": "24208-816_cb6890c5-7788-453b-910d-10c2bee17d04", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "24208-816", "generic_name": "Timolol Maleate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timoptic-XE", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA020330", "marketing_category": "NDA", "marketing_start_date": "20160531", "listing_expiration_date": "20261231"}