42291-413 : Dofetilide 500 ug/1 Oral Capsule


NDC: 42291-413
Labeler: Avkare, Inc.
Product Type: Human Prescription Drug
Drug Name:  Dofetilide
Dosage Form: Oral Capsule
Application #: ANDA207746
Rev. Date: 


Appearance:


Markings: 46
Shapes:  Capsule
Colors:  Pink
Size (mm): 18
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 42291-413-60: 60 CAPSULE IN 1 BOTTLE, PLASTIC (42291‑413‑60)

Active Ingredients:

  • Dofetilide

Dosage Strength:

  • 500 ug/1

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Starch, Pregelatinized Corn
  • Silicon Dioxide
  • Magnesium Stearate
  • Anhydrous Citric Acid
  • Copovidone
  • Fd&c Red No. 40
  • D&c Yellow No. 10
  • Titanium Dioxide
  • Sodium Lauryl Sulfate
  • Gelatin
  • Ammonia
  • Ferrosoferric Oxide
  • Butyl Alcohol
  • Alcohol
  • Isopropyl Alcohol
  • Potassium Hydroxide
  • Propylene Glycol
  • Shellac /

Pharmaceutical Classes:

  • Antiarrhythmic [EPC]

Related Products:

Based on records with the same trade name.
  • 42291-411 Dofetilide 125 ug/1 Oral Capsule by Avkare, Inc.
  • 42291-412 Dofetilide 250 ug/1 Oral Capsule by Avkare, Inc.
  • 0904-6681 Dofetilide .125 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6682 Dofetilide .25 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6683 Dofetilide .5 mg Oral Capsule by Major Pharmaceuticals
  • 16714-840 Dofetilide .125 mg Oral Capsule by Northstar Rx LLC
  • 16714-841 Dofetilide .25 mg Oral Capsule by Northstar Rx LLC
  • 16714-842 Dofetilide .5 mg Oral Capsule by Northstar Rx LLC
  • 16729-490 Dofetilide .125 mg Oral Capsule by Accord Healthcare, Inc.
  • 16729-491 Dofetilide .25 mg Oral Capsule by Accord Healthcare, Inc.
  • 16729-492 Dofetilide .5 mg Oral Capsule by Accord Healthcare, Inc.
  • 42794-044 Dofetilide 125 ug/1 Oral Capsule by Sigmapharm Laboratories, LLC
  • 42794-045 Dofetilide 250 ug/1 Oral Capsule by Sigmapharm Laboratories, LLC
  • 42794-046 Dofetilide 500 ug/1 Oral Capsule by Sigmapharm Laboratories, LLC
  • 47335-061 Dofetilide .125 mg Oral Capsule by Sun Pharmaceutical Industries, Inc.
  • 47335-062 Dofetilide .25 mg Oral Capsule by Sun Pharmaceutical Industries, Inc.
  • 47335-063 Dofetilide .5 mg Oral Capsule by Sun Pharmaceutical Industries, Inc.
  • 50742-230 Dofetilide .125 mg Oral Capsule by Ingenus Pharmaceuticals, LLC
  • 50742-231 Dofetilide .25 mg Oral Capsule by Ingenus Pharmaceuticals, LLC
  • 50742-232 Dofetilide .5 mg Oral Capsule by Ingenus Pharmaceuticals, LLC
  • More related products ...

NDC 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.