NDC 13672-053

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 ID: 13672-053_754a6348-953f-4e8e-e053-2991aa0adde2
• NDC: 13672-053
• Product Type: Human Prescription Drug
• Proprietary Name: Betapace
• Generic Name: Sotalol Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1992-10-30
• Marketing Category: NDA / NDA
• Application Number: NDA019865
• Labeler Name: SkyePharma Production SAS
• Substance Name: SOTALOL HYDROCHLORIDE
• Active Ingredient Strength: 160 mg/160mg
• Pharm Classes: Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 13672-053-00

100 mg in 1 BOTTLE (13672-053-00)

• Marketing Start Date: 1992-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13672-053-00 [13672005300]

Betapace TABLET

• Marketing Category: NDA
• Application Number: NDA019865
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-10-30

Drug Details

Active Ingredients

Ingredient	Strength
SOTALOL HYDROCHLORIDE	160 mg/160mg

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
13672-051	Betapace	sotalol HCl
13672-052	Betapace	sotalol HCl
13672-053	Betapace	sotalol HCl
70515-105	BETAPACE	sotalol hydrochloride
70515-106	BETAPACE	sotalol hydrochloride
70515-109	BETAPACE	sotalol hydrochloride
13672-054	Betapace AF	sotalol HCl
13672-055	Betapace AF	sotalol HCl
13672-056	Betapace AF	sotalol HCl