65224-800 : Cedax 400 mg Oral Capsule


NDC: 65224-800
Labeler: Pernix Therapeutics, LLC
Product Type: Human Prescription Drug
Drug Name:  Cedax
Dosage Form: Oral Capsule
Application #: NDA050685
Rev. Date: 


Appearance:


Markings: Cedax;400;mg
Shapes:  Capsule
Colors:  White
Size (mm): 22
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:

  • 65224-800-22: 20 CAPSULE IN 1 BOTTLE (65224‑800‑22)
  • 65224-800-99: 1 CAPSULE IN 1 POUCH (65224‑800‑99)

Active Ingredients:

  • Ceftibuten Dihydrate

Dosage Strength:

  • 400 mg

Inactive Ingredients:

  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Sodium Starch Glycolate Type a Potato
  • Gelatin
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Polysorbate 80
  • Benzyl Alcohol
  • Sodium Propionate
  • Edetate Calcium Disodium
  • Butylparaben
  • Propylparaben
  • Methylparaben

Pharmaceutical Classes:

  • Cephalosporin Antibacterial [EPC]
  • Cephalosporins [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 65224-802 Cedax 90 mg/5ml Oral Suspension by Pernix Therapeutics, LLC
  • 65224-804 Cedax 180 mg/5ml Oral Suspension by Pernix Therapeutics, LLC
  • 59630-820 Cedax 400 mg Oral Capsule by Sciele Pharma, Inc.
  • 59630-821 Cedax 18 mg/ml Oral Suspension by Sciele Pharma, Inc.

NDC QR Code

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NDC 65224-800 QR Code

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Related Discussions:

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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.