NDC 0378-1200

Acebutolol Hydrochloride

Acebutolol Hydrochloride

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

Product ID0378-1200_b46207aa-b4bb-4637-85d3-e7ea5c2004bc
NDC0378-1200
Product TypeHuman Prescription Drug
Proprietary NameAcebutolol Hydrochloride
Generic NameAcebutolol Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1995-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA074288
Labeler NameMylan Pharmaceuticals Inc.
Substance NameACEBUTOLOL HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-1200-01

100 CAPSULE in 1 BOTTLE (0378-1200-01)
Marketing Start Date1995-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1200-01 [00378120001]

Acebutolol Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA074288
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-04-24

Drug Details

Active Ingredients

IngredientStrength
ACEBUTOLOL HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:6bfb00a0-c057-4dfb-9ae3-e5b7d782cd24
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.