NDC 55545-1001

TIMOLOL MALEATE

Timolol Maleate

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

Product ID55545-1001_5de7796b-8c4b-4e1a-96c2-3ee63a576a68
NDC55545-1001
Product TypeHuman Prescription Drug
Proprietary NameTIMOLOL MALEATE
Generic NameTimolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA077259
Labeler NameFDC Limited
Substance NameTIMOLOL MALEATE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55545-1001-2

1 BOTTLE in 1 CARTON (55545-1001-2) > 10 mL in 1 BOTTLE
Marketing Start Date2014-12-15
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
TIMOLOL MALEATE5 mg/mL

OpenFDA Data

SPL SET ID:42887224-997c-4f08-8e2c-918de7195a6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992303
  • Pharmacological Class

    • 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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