NDC 17478-366

Timolol Maleate

Timolol

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.

Product ID17478-366_809862e0-3bc1-4dd4-850e-97bd3f2a0cb3
NDC17478-366
Product TypeHuman Prescription Drug
Proprietary NameTimolol Maleate
Generic NameTimolol
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA205309
Labeler NameAkorn, Inc.
Substance NameTIMOLOL
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 17478-366-05

1 BOTTLE, DROPPER in 1 CARTON (17478-366-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-366-10 [17478036610]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA205309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

NDC 17478-366-05 [17478036605]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA205309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

NDC 17478-366-15 [17478036615]

Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA205309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL5 mg/mL

OpenFDA Data

SPL SET ID:46726565-6d61-736f-6e73-344576657221
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992303
  • 1923428
  • UPC Code
  • 0317478366058
  • 0317478365051
  • 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"

    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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