NDC 10135-623

Betaxolol

Betaxolol

Betaxolol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Betaxolol Hydrochloride.

Product ID10135-623_57968420-5df5-4b0c-ab16-5bb526a908e5
NDC10135-623
Product TypeHuman Prescription Drug
Proprietary NameBetaxolol
Generic NameBetaxolol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA075541
Labeler NameMarlex Pharmaceuticals Inc
Substance NameBETAXOLOL HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10135-623-01

100 TABLET, FILM COATED in 1 BOTTLE (10135-623-01)
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-623-01 [10135062301]

Betaxolol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BETAXOLOL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:4aa6e51b-80a3-4022-87e2-0692f24ae9ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297757
  • 1297753
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Betaxolol" or generic name "Betaxolol"

    NDCBrand NameGeneric Name
    10135-623BetaxololBetaxolol
    10135-624BetaxololBetaxolol
    17478-705BetaxololBetaxolol Hydrochloride
    24658-700BetaxololBetaxolol
    24658-701BetaxololBetaxolol
    42806-038BetaxololBetaxolol
    42806-039BetaxololBetaxolol
    60429-753BetaxololBetaxolol
    60429-754BetaxololBetaxolol

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