44009-802 : Cefditoren Pivoxil 400 mg Oral Tablet


NDC: 44009-802
Labeler: Pharma Romlev Inc.
Product Type: Human Prescription Drug
Drug Name:  Cefditoren Pivoxil
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021222
Rev. Date: 


Appearance:


Markings: CBP400
Shapes:  Oval
Colors:  White
Size (mm): 5
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:

  • 44009-802-20: 20 TABLET, FILM COATED IN 1 BLISTER PACK (44009‑802‑20)
  • 44009-802-28: 28 TABLET, FILM COATED IN 1 BLISTER PACK (44009‑802‑28)

Active Ingredients:

  • Cefditoren Pivoxil

Dosage Strength:

  • 400 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Mannitol
  • Magnesium Stearate
  • Sodium Caseinate
  • Sodium Tripolyphosphate
  • Hydroxypropyl Cellulose
  • Carnauba Wax
  • Polyethylene Glycols
  • Titanium Dioxide
  • D&c Red No. 27
  • Fd&c Blue No. 1
  • Hypromelloses
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

  • Cephalosporin Antibacterial [EPC]
  • Cephalosporins [CS]

Related Products:

Based on records with the same trade name.
  • 44009-801 Cefditoren Pivoxil 200 mg Oral Tablet by Pharma Romlev Inc.
  • 24486-801 Cefditoren Pivoxil 200 mg Oral Tablet by Aristos Phamaceuticals, Inc.
  • 24486-802 Cefditoren Pivoxil 400 mg Oral Tablet by Aristos Phamaceuticals, Inc.

NDC QR Code

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NDC 44009-802 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.