NDC 13672-051

Betapace

Sotalol Hcl

Betapace is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Skyepharma Production Sas. The primary component is Sotalol Hydrochloride.

Product ID13672-051_754a6348-953f-4e8e-e053-2991aa0adde2
NDC13672-051
Product TypeHuman Prescription Drug
Proprietary NameBetapace
Generic NameSotalol Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1992-10-30
Marketing CategoryNDA / NDA
Application NumberNDA019865
Labeler NameSkyePharma Production SAS
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/80mg
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13672-051-00

100 mg in 1 BOTTLE (13672-051-00)
Marketing Start Date1992-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13672-051-00 [13672005100]

Betapace TABLET
Marketing CategoryNDA
Application NumberNDA019865
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-10-30

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/80mg

Pharmacological Class

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

NDC Crossover Matching brand name "Betapace" or generic name "Sotalol Hcl"

NDCBrand NameGeneric Name
13672-051Betapacesotalol HCl
13672-052Betapacesotalol HCl
13672-053Betapacesotalol HCl
70515-105BETAPACEsotalol hydrochloride
70515-106BETAPACEsotalol hydrochloride
70515-109BETAPACEsotalol hydrochloride
13672-054Betapace AFsotalol HCl
13672-055Betapace AFsotalol HCl
13672-056Betapace AFsotalol HCl

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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