NDC 50383-021

Timolol Maleate

Timolol Maleate

Timolol Maleate is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Timolol Maleate.

Product ID50383-021_66806aed-f023-4e82-98b5-fd361bf15afe
NDC50383-021
Product TypeHuman Prescription Drug
Proprietary NameTimolol Maleate
Generic NameTimolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2002-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA075163
Labeler NameAkorn
Substance NameTIMOLOL MALEATE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-021-05

1 BOTTLE in 1 CARTON (50383-021-05) > 5 mL in 1 BOTTLE
Marketing Start Date2002-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-021-10 [50383002110]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA075163
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-09-10

NDC 50383-021-15 [50383002115]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA075163
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-09-10

NDC 50383-021-05 [50383002105]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA075163
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-09-10

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE5 mg/mL

OpenFDA Data

SPL SET ID:63f36fa6-bd5a-49b2-b7bf-28ce0db3c6dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992303
  • Pharmacological Class

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

    Medicade Reported Pricing

    50383002115 TIMOLOL 0.5% EYE DROPS

    Pricing Unit: ML | Drug Type:

    50383002110 TIMOLOL 0.5% EYE DROPS

    Pricing Unit: ML | Drug Type:

    50383002105 TIMOLOL 0.5% EYE DROPS

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Timolol Maleate" or generic name "Timolol Maleate"

    NDCBrand NameGeneric Name
    0378-0055Timolol Maleatetimolol maleate
    0378-0221Timolol Maleatetimolol maleate
    0378-0715Timolol Maleatetimolol maleate
    13811-618Timolol MaleateTimolol Maleate
    13811-619Timolol MaleateTimolol Maleate
    13811-620Timolol MaleateTimolol Maleate
    17478-189Timolol MaleateTimolol
    17478-288Timolol MaleateTimolol Maleate
    17478-289Timolol MaleateTimolol Maleate
    17478-365Timolol MaleateTimolol
    17478-366Timolol MaleateTimolol
    67877-229Timolol MaleateTimolol Maleate
    68071-1563Timolol MaleateTimolol Maleate
    68071-1558TIMOLOL MALEATETIMOLOL MALEATE
    68682-045Timolol MaleateTimolol Maleate
    69189-0496Timolol MaleateTimolol Maleate
    70518-1211Timolol MaleateTimolol Maleate
    24208-818Timolol MaleateTimolol Maleate
    24208-819Timolol MaleateTimolol Maleate
    50090-1852TIMOLOL MALEATETIMOLOL MALEATE
    50383-021Timolol MaleateTimolol Maleate
    50090-3441Timolol MaleateTimolol Maleate
    55545-1000TIMOLOL MALEATETIMOLOL MALEATE
    55545-1001TIMOLOL MALEATETIMOLOL MALEATE
    60505-1005Timolol MaleateTimolol Maleate
    60758-801TIMOLOL MALEATETIMOLOL MALEATE
    61314-227Timolol MaleateTimolol Maleate
    60758-802TIMOLOL MALEATETIMOLOL MALEATE
    61314-226Timolol MaleateTimolol Maleate
    63629-7167Timolol MaleateTimolol Maleate
    64980-514TIMOLOL MALEATETIMOLOL MALEATE
    64980-513TIMOLOL MALEATETIMOLOL MALEATE
    70518-2354TIMOLOL MALEATETIMOLOL MALEATE
    70518-2353TIMOLOL MALEATETIMOLOL MALEATE
    76519-1163TIMOLOL MALEATETIMOLOL MALEATE
    24208-004IstalolTimolol Maleate
    0187-1496Timoptic in OcudoseTimolol Maleate
    0187-1498Timoptic in OcudoseTimolol Maleate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.