NDC 10544-286

Propranolol Hydrochloride ER

Propranolol Hydrochloride

Propranolol Hydrochloride ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Propranolol Hydrochloride.

Product ID10544-286_1350786d-28a6-3b80-e054-00144ff8d46c
NDC10544-286
Product TypeHuman Prescription Drug
Proprietary NamePropranolol Hydrochloride ER
Generic NamePropranolol Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-11-18
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA018553
Labeler NameBlenheim Pharmacal, Inc.
Substance NamePROPRANOLOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-286-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10544-286-30)
Marketing Start Date2014-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-286-30 [10544028630]

Propranolol Hydrochloride ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA018553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:0fc60597-a43b-1a0f-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856569
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Propranolol Hydrochloride ER" or generic name "Propranolol Hydrochloride"

    NDCBrand NameGeneric Name
    71335-0387Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    71335-0907Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    71335-0731Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    10544-286Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    43478-902Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    43478-900Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    43478-901Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    43478-903Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    50436-0902Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    61919-489PROPRANOLOL HYDROCHLORIDE ERPROPRANOLOL HYDROCHLORIDE ER
    62559-533Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    62559-530Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    62559-531Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    62559-532Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    63629-7176Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    60760-538Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    63629-1968Propranolol Hydrochloride ERPropranolol Hydrochloride ER
    0054-3727Propranolol HydrochloridePropranolol Hydrochloride
    0054-3730Propranolol HydrochloridePropranolol Hydrochloride
    0115-1659Propranolol HydrochloridePropranolol Hydrochloride
    0115-1660Propranolol HydrochloridePropranolol Hydrochloride
    0115-1661Propranolol HydrochloridePropranolol Hydrochloride
    0115-1662Propranolol HydrochloridePropranolol Hydrochloride
    0115-1693Propranolol HydrochloridePropranolol Hydrochloride
    0121-0908Propranolol HydrochloridePropranolol Hydrochloride
    0143-9872Propranolol HydrochloridePropranolol Hydrochloride
    0228-2778Propranolol HydrochloridePropranolol Hydrochloride
    0228-2779Propranolol HydrochloridePropranolol Hydrochloride
    0228-2780Propranolol HydrochloridePropranolol Hydrochloride
    0228-2781Propranolol HydrochloridePropranolol Hydrochloride
    0378-0182Propranolol Hydrochloridepropranolol hydrochloride
    0378-0183Propranolol Hydrochloridepropranolol hydrochloride
    0378-0184Propranolol Hydrochloridepropranolol hydrochloride
    0378-0185Propranolol Hydrochloridepropranolol hydrochloride
    0378-0187Propranolol Hydrochloridepropranolol hydrochloride
    0404-9944PROPRANOLOL HYDROCHLORIDEpropranolol hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.