NDC 61919-489

PROPRANOLOL HYDROCHLORIDE ER

Propranolol Hydrochloride Er

PROPRANOLOL HYDROCHLORIDE ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Propranolol Hydrochloride.

Product ID61919-489_5c370417-eff1-7280-e053-2a91aa0a1446
NDC61919-489
Product TypeHuman Prescription Drug
Proprietary NamePROPRANOLOL HYDROCHLORIDE ER
Generic NamePropranolol Hydrochloride Er
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-10-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA018553
Labeler NameDirect Rx
Substance NamePROPRANOLOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-489-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-489-30)
Marketing Start Date2017-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-489-30 [61919048930]

PROPRANOLOL HYDROCHLORIDE ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA018553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-27

Drug Details

Active Ingredients

IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:5c370417-eff0-7280-e053-2a91aa0a1446
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856535
  • 856569
  • Pharmacological Class

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

    NDC Crossover Matching brand name "PROPRANOLOL HYDROCHLORIDE ER" or generic name "Propranolol Hydrochloride Er"

    NDCBrand NameGeneric Name
    61919-489PROPRANOLOL HYDROCHLORIDE ERPROPRANOLOL HYDROCHLORIDE ER
    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
    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

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