50419-105 : Betapace 80 mg Oral Tablet


NDC: 50419-105
Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Betapace
Dosage Form: Oral Tablet
Application #: NDA019865
Rev. Date: 


Appearance:


Markings: Betapace;80;mg
Shapes:  Oval
Colors:  Blue
Size (mm): 12
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

Betapace 80 mg: (50419-105) Betapace 80 mg Oral Tablet by Bayer Healthcare Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 50419-105-10: 100 TABLET IN 1 BOTTLE (50419‑105‑10)

Active Ingredients:

  • Sotalol Hydrochloride

Dosage Strength:

  • 80 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Stearic Acid
  • Magnesium Stearate
  • Silicon Dioxide
  • Fd&c Blue No. 2

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50419-106 Betapace 160 mg Oral Tablet by Bayer Healthcare Pharmaceuticals Inc.
  • 50419-109 Betapace 120 mg Oral Tablet by Bayer Healthcare Pharmaceuticals Inc.
  • 13672-051 Betapace 80 mg/80mg Oral Tablet by Skyepharma Production Sas
  • 13672-052 Betapace 120 mg/120mg Oral Tablet by Skyepharma Production Sas
  • 13672-053 Betapace 160 mg/160mg Oral Tablet by Skyepharma Production Sas
  • 70515-105 Betapace 80 mg Oral Tablet by Covis Pharma
  • 70515-106 Betapace 160 mg Oral Tablet by Covis Pharma
  • 70515-109 Betapace 120 mg Oral Tablet by Covis Pharma
  • 83107-005 Betapace 80 mg Oral Tablet by Legacy Pharma USA, Inc.
  • 83107-006 Betapace 120 mg Oral Tablet by Legacy Pharma USA, Inc.
  • 83107-007 Betapace 160 mg Oral Tablet by Legacy Pharma USA, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 50419-105 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.