NDC 0187-1498

Timoptic in Ocudose

Timolol Maleate

Timoptic in Ocudose is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Americas Inc.. The primary component is Timolol Maleate.

Product ID0187-1498_3c78fc49-f99e-495b-bcd5-45faf832190a
NDC0187-1498
Product TypeHuman Prescription Drug
Proprietary NameTimoptic in Ocudose
Generic NameTimolol Maleate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1986-11-05
Marketing CategoryNDA / NDA
Application NumberNDA019463
Labeler NameBausch Health Americas Inc.
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 0187-1498-25

4 POUCH in 1 CARTON (0187-1498-25) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER
Marketing Start Date1986-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-1498-25 [00187149825]

Timoptic in Ocudose SOLUTION
Marketing CategoryNDA
Application NumberNDA019463
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-11-05

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE3.4 mg/mL

OpenFDA Data

SPL SET ID:c1293d51-b633-486c-8e13-fcf60063faeb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1922876
  • 1922877
  • 1922894
  • 1922895

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Timoptic in Ocudose" or generic name "Timolol Maleate"

    NDCBrand NameGeneric Name
    0187-1496Timoptic in OcudoseTimolol Maleate
    0187-1498Timoptic in OcudoseTimolol Maleate
    24208-498Timoptic in OcudoseTimolol Maleate
    24208-499Timoptic in OcudoseTimolol Maleate
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.