NDC 10135-631

Acebutolol Hydrochloride

Acebutolol Hydrochloride

Acebutolol Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Acebutolol Hydrochloride.

Product ID10135-631_66c709a0-85f5-4c8c-81cf-62bc7752f282
NDC10135-631
Product TypeHuman Prescription Drug
Proprietary NameAcebutolol Hydrochloride
Generic NameAcebutolol Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-10-20
Marketing CategoryANDA / ANDA
Application NumberANDA075047
Labeler NameMarlex Pharmaceuticals Inc
Substance NameACEBUTOLOL HYDROCHLORIDE
Active Ingredient Strength400 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 10135-631-01

100 CAPSULE in 1 BOTTLE (10135-631-01)
Marketing Start Date2017-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-631-01 [10135063101]

Acebutolol Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-20

Drug Details

Active Ingredients

IngredientStrength
ACEBUTOLOL HYDROCHLORIDE400 mg/1

OpenFDA Data

SPL SET ID:1620c4d3-6a6e-49be-b002-8e4358b0c7d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998689
  • 998685

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Acebutolol Hydrochloride" or generic name "Acebutolol Hydrochloride"

    NDCBrand NameGeneric Name
    0378-1200Acebutolol Hydrochlorideacebutolol hydrochloride
    0378-1400Acebutolol Hydrochlorideacebutolol hydrochloride
    10135-630Acebutolol HydrochlorideAcebutolol Hydrochloride
    10135-631Acebutolol HydrochlorideAcebutolol Hydrochloride
    42291-101Acebutolol HydrochlorideAcebutolol Hydrochloride
    42291-102Acebutolol HydrochlorideAcebutolol Hydrochloride
    50268-050Acebutolol HydrochlorideAcebutolol Hydrochloride
    51407-666Acebutolol HydrochlorideAcebutolol Hydrochloride
    51407-667Acebutolol HydrochlorideAcebutolol Hydrochloride
    53746-669Acebutolol HydrochlorideAcebutolol Hydrochloride
    53746-670Acebutolol HydrochlorideAcebutolol Hydrochloride
    62559-255Acebutolol HydrochlorideAcebutolol Hydrochloride
    62559-256Acebutolol HydrochlorideAcebutolol Hydrochloride
    65162-669Acebutolol HydrochlorideAcebutolol Hydrochloride
    65162-670Acebutolol HydrochlorideAcebutolol Hydrochloride
    67857-700SECTRALacebutolol hydrochloride
    67857-701SECTRALacebutolol hydrochloride
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