NDC 17478-289

Timolol Maleate

Timolol Maleate

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

Product ID17478-289_38f342bb-668c-4343-b700-74ecdd37db8a
NDC17478-289
Product TypeHuman Prescription Drug
Proprietary NameTimolol Maleate
Generic NameTimolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2012-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA074465
Labeler NameAkorn, Inc.
Substance NameTIMOLOL MALEATE
Active Ingredient Strength3 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 17478-289-10

1 BOTTLE, DROPPER in 1 CARTON (17478-289-10) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2012-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-289-11 [17478028911]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA074465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-26

NDC 17478-289-12 [17478028912]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA074465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-26

NDC 17478-289-25 [17478028925]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA074465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-26

NDC 17478-289-10 [17478028910]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA074465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-26

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE2.5 mg/mL

OpenFDA Data

SPL SET ID:c9726422-f794-4d39-a437-17dcb8c0f3b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992303
  • 1923428
    • UPC Code
  • 0317478288107

    • Pharmacological Class

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

    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
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