NDC 70515-106

BETAPACE

Sotalol Hydrochloride

BETAPACE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Covis Pharma Us, Inc. The primary component is Sotalol Hydrochloride.

Product ID70515-106_1b3fb38e-5546-4a55-866f-d2e2ffadaed8
NDC70515-106
Product TypeHuman Prescription Drug
Proprietary NameBETAPACE
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-09-01
Marketing CategoryNDA / NDA
Application NumberNDA019865
Labeler NameCovis Pharma US, Inc
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength160 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70515-106-10

100 TABLET in 1 BOTTLE (70515-106-10)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70515-106-10 [70515010610]

BETAPACE TABLET
Marketing CategoryNDA
Application NumberNDA019865
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-01

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE160 mg/1

OpenFDA Data

SPL SET ID:afce2787-8899-4098-87c8-f1e8dd19e6dd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923424
  • 1923425
  • 1922764
  • 1922765
  • 1922766
  • 1922763
  • 1922720
  • 1922721
  • 1923426
  • 1923427
  • 1923422
  • 1923423
    • UPC Code
  • 0370515119062
  • 0370515116061
  • 0370515109100
  • 0370515115064
  • 0370515106109
  • 0370515105102

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]
    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]

    NDC Crossover Matching brand name "BETAPACE" or generic name "Sotalol Hydrochloride"

    NDCBrand NameGeneric Name
    70515-109BETAPACEBETAPACE
    70515-106BETAPACEBETAPACE
    70515-105BETAPACEBETAPACE
    13672-053BetapaceBetapace
    13672-052BetapaceBetapace
    13672-051BetapaceBetapace
    0245-0012SorineSotalol Hydrochloride
    0245-0013SorineSotalol Hydrochloride
    0245-0014SorineSotalol Hydrochloride
    0245-0015SorineSotalol Hydrochloride
    10135-661SotalolSotalol Hydrochloride
    10135-662SotalolSotalol Hydrochloride
    10135-663SotalolSotalol Hydrochloride
    0093-1060Sotalol HydrochlorideSotalol Hydrochloride
    0093-1061Sotalol HydrochlorideSotalol Hydrochloride
    0093-1062Sotalol HydrochlorideSotalol Hydrochloride
    0093-1063Sotalol HydrochlorideSotalol Hydrochloride
    0185-0170sotalol hydrochloridesotalol hydrochloride
    0185-0171sotalol hydrochloridesotalol hydrochloride
    0185-0174sotalol hydrochloridesotalol hydrochloride
    0185-0177sotalol hydrochloridesotalol hydrochloride
    0378-5123Sotalol Hydrochloridesotalol hydrochloride
    0378-5124Sotalol Hydrochloridesotalol hydrochloride
    0378-5125Sotalol Hydrochloridesotalol hydrochloride
    0603-5769Sotalol HydrochlorideSotalol Hydrochloride
    0603-5770Sotalol HydrochlorideSotalol Hydrochloride
    0603-5771Sotalol HydrochlorideSotalol Hydrochloride
    0603-5772Sotalol HydrochlorideSotalol Hydrochloride
    0615-5552Sotalol HydrochlorideSotalol Hydrochloride
    0615-7888Sotalol HydrochlorideSotalol Hydrochloride
    0904-7143Sotalol HydrochlorideSotalol Hydrochloride

    Trademark Results [BETAPACE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BETAPACE
    BETAPACE
    73701175 1504551 Live/Registered
    BRISTOL-MYERS COMPANY
    1987-12-15
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