50419-116 : Betapace 160 mg Oral Tablet


NDC50419-116
Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Betapace Af
Dosage Form: Oral Tablet
Application #: NDA021151
Rev. Date: 


Appearance:


Markings: BHCP;160;mg
Shapes:  Oval
Colors:  White
Size (mm): 15
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.

BHCP 160 mg: (50419-116) Betapace 160 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:

  • 50419-116-06: 1 BOTTLE, PLASTIC IN 1 PACKAGE (50419‑116‑06) > 60 TABLET IN 1 BOTTLE, PLASTIC

Active Ingredients:

  • Sotalol Hydrochloride

Dosage Strength:

  • 160 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50419-115 Betapace 80 mg Oral Tablet by Bayer Healthcare Pharmaceuticals Inc.
  • 50419-119 Betapace 120 mg Oral Tablet by Bayer Healthcare Pharmaceuticals Inc.
  • 13672-054 Betapace Af 80 mg/80mg Oral Tablet by Skyepharma Production Sas
  • 13672-055 Betapace Af 120 mg/120mg Oral Tablet by Skyepharma Production Sas
  • 13672-056 Betapace Af 160 mg/160mg Oral Tablet by Skyepharma Production Sas
  • 70515-115 Betapace Af 80 mg Oral Tablet by Covis Pharma
  • 70515-116 Betapace Af 160 mg Oral Tablet by Covis Pharma
  • 70515-119 Betapace Af 120 mg Oral Tablet by Covis Pharma
  • 83107-008 Betapace Af 80 mg Oral Tablet by Legacy Pharma USA, Inc.
  • 83107-009 Betapace Af 120 mg Oral Tablet by Legacy Pharma USA, Inc.
  • 83107-010 Betapace Af 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 50419-116 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.