NDC 0378-0221

Timolol Maleate

Timolol Maleate

Timolol Maleate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Timolol Maleate.

Product ID0378-0221_51da49e0-2432-4c73-b876-1e110edc7fd9
NDC0378-0221
Product TypeHuman Prescription Drug
Proprietary NameTimolol Maleate
Generic NameTimolol Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1990-06-08
Marketing CategoryANDA / ANDA
Application NumberANDA072668
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTIMOLOL MALEATE
Active Ingredient Strength10 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-0221-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)
Marketing Start Date1990-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0221-01 [00378022101]

Timolol Maleate TABLET
Marketing CategoryANDA
Application NumberANDA072668
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-06-08

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE10 mg/1

OpenFDA Data

SPL SET ID:57c62928-63d8-4505-9b9e-c085a3a12c95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198286
  • 198284
  • 198285
  • 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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