NDC 70515-105

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 ID: 70515-105_1b3fb38e-5546-4a55-866f-d2e2ffadaed8
• NDC: 70515-105
• Product Type: Human Prescription Drug
• Proprietary Name: BETAPACE
• Generic Name: Sotalol Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA019865
• Labeler Name: Covis Pharma US, Inc
• Substance Name: SOTALOL HYDROCHLORIDE
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 70515-105-10

100 TABLET in 1 BOTTLE (70515-105-10)

• Marketing Start Date: 2016-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70515-105-10 [70515010510]

BETAPACE TABLET

• Marketing Category: NDA
• Application Number: NDA019865
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-01

Drug Details

Active Ingredients

Ingredient	Strength
SOTALOL HYDROCHLORIDE	80 mg/1

OpenFDA Data

• SPL SET ID: afce2787-8899-4098-87c8-f1e8dd19e6dd
• Manufacturer:
  • Covis Pharma
• UNII:
  • HEC37C70XX
• 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"

NDC	Brand Name	Generic Name
70515-109	BETAPACE	BETAPACE
70515-106	BETAPACE	BETAPACE
70515-105	BETAPACE	BETAPACE
13672-053	Betapace	Betapace
13672-052	Betapace	Betapace
13672-051	Betapace	Betapace
0245-0012	Sorine	Sotalol Hydrochloride
0245-0013	Sorine	Sotalol Hydrochloride
0245-0014	Sorine	Sotalol Hydrochloride
0245-0015	Sorine	Sotalol Hydrochloride
10135-661	Sotalol	Sotalol Hydrochloride
10135-662	Sotalol	Sotalol Hydrochloride
10135-663	Sotalol	Sotalol Hydrochloride
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride
0185-0170	sotalol hydrochloride	sotalol hydrochloride
0185-0171	sotalol hydrochloride	sotalol hydrochloride
0185-0174	sotalol hydrochloride	sotalol hydrochloride
0185-0177	sotalol hydrochloride	sotalol hydrochloride
0378-5123	Sotalol Hydrochloride	sotalol hydrochloride
0378-5124	Sotalol Hydrochloride	sotalol hydrochloride
0378-5125	Sotalol Hydrochloride	sotalol hydrochloride
0603-5769	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5770	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5771	Sotalol Hydrochloride	Sotalol Hydrochloride
0603-5772	Sotalol Hydrochloride	Sotalol Hydrochloride
0615-5552	Sotalol Hydrochloride	Sotalol Hydrochloride
0615-7888	Sotalol Hydrochloride	Sotalol Hydrochloride
0904-7143	Sotalol Hydrochloride	Sotalol Hydrochloride