NDC 24208-814

Timoptic-XE

Timolol Maleate

Timoptic-XE is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Timolol Maleate.

Product ID24208-814_783bfaf1-624b-4aaf-8c93-bd24323a391e
NDC24208-814
Product TypeHuman Prescription Drug
Proprietary NameTimoptic-XE
Generic NameTimolol Maleate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-05-31
Marketing CategoryNDA / NDA
Application NumberNDA020330
Labeler NameBausch & Lomb Incorporated
Substance NameTIMOLOL MALEATE
Active Ingredient Strength3 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24208-814-25

1 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) > 5 mL in 1 BOTTLE, DISPENSING
Marketing Start Date2016-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24208-814-25 [24208081425]

Timoptic-XE SOLUTION
Marketing CategoryNDA
Application NumberNDA020330
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE2.5 mg/mL

OpenFDA Data

SPL SET ID:a4d03de7-06b7-4cfc-9d1b-616969df209c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861420
  • 313408
  • 313407
  • 861422

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Timoptic-XE" or generic name "Timolol Maleate"

    NDCBrand NameGeneric Name
    24208-816Timoptic-XETimoptic-XE
    24208-814Timoptic-XETimoptic-XE
    24208-004IstalolTimolol Maleate
    0378-0055Timolol Maleatetimolol maleate
    0378-0221Timolol Maleatetimolol maleate
    0378-0715Timolol Maleatetimolol maleate
    13811-618Timolol MaleateTimolol Maleate
    13811-619Timolol MaleateTimolol Maleate
    13811-620Timolol MaleateTimolol Maleate
    17478-288Timolol MaleateTimolol Maleate
    17478-289Timolol MaleateTimolol Maleate
    24208-496Timolol MaleateTimolol Maleate
    24208-812TimopticTimolol Maleate
    0187-1496Timoptic in OcudoseTimolol Maleate
    0187-1498Timoptic in OcudoseTimolol Maleate
    24208-498Timoptic in OcudoseTimolol Maleate
    24208-499Timoptic in OcudoseTimolol Maleate

    Trademark Results [Timoptic-XE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIMOPTIC-XE
    TIMOPTIC-XE
    74328278 1902106 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    1992-11-04
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.