54868-5171 : Ketek 400 mg Oral Tablet


NDC: 54868-5171
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Ketek
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021144
Rev. Date: 


Appearance:


Markings: H3647;400
Shapes:  Oval
Colors:  Orange
Size (mm): 13
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.

H3647 400: (0088-2225) Ketek 400 mg Oral Tablet by Physicians Total Care, 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:

  • 54868-5171-0: 1 BLISTER PACK IN 1 BOX (54868‑5171‑0) > 10 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Telithromycin

Dosage Strength:

  • 400 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol
  • Povidone
  • Ferric Oxide Red
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Ketolide Antibacterial [EPC]
  • Ketolides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0088-2223 Ketek 300 mg Oral Tablet by Sanofi-aventis U.S. LLC
  • 0088-2225 Ketek 400 mg Oral Tablet by Sanofi-aventis U.S. LLC

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 54868-5171 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.