10122-801 : Spectracef 200 mg Oral Tablet


NDC10122-801
Labeler: Cornerstone Therapeutics Inc.
Product Type: Human Prescription Drug
Drug Name:  Spectracef
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021222
Rev. Date: 


Appearance:


Markings: CBP;200
Shapes:  Oval
Colors:  White
Size (mm): 17
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:

  • 10122-801-20: 20 TABLET, FILM COATED IN 1 BLISTER PACK (10122‑801‑20)

Active Ingredients:

  • Cefditoren Pivoxil

Dosage Strength:

  • 200 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 10122-802 Spectracef 400 mg Oral Tablet by Cornerstone Therapeutics Inc.
  • 44004-801 Spectracef 200 mg Oral Tablet by Vansen Pharma Inc.
  • 44004-802 Spectracef 400 mg Oral Tablet by Vansen Pharma Inc.

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.