65224-707 : Omeclamox-pak


NDC65224-707
Labeler: Pernix Therapeutics, LLC
Product Type: Human Prescription Drug
Drug Name:  Omeclamox-pak
Dosage Form: Kit
Application #: NDA050824
Rev. Date: 


Appearance:


Markings: 54;312
R;158;Omeprazol;20;mg
WC;731
Shapes:  Capsule
Oval
Colors:  Gray
White
Orange
Size (mm): 18
19
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:

  • 65224-707-11: 10 BLISTER PACK IN 1 CARTON (65224‑707‑11) > 1 KIT IN 1 BLISTER PACK

Active Ingredients:

  • Omeprazole
  • Clarithromycin
  • Amoxicillin

Kit Contents:

  • Amoxicillin
  • Clarithromycin
  • Omeprazole

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hypromellose 2208 (100 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycols
  • Povidone
  • Stearic Acid
  • Talc
  • Titanium Dioxide
  • Triacetin
  • Crospovidone
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Mannitol
  • Meglumine
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Peg/Ppg-30/160 Copolymer
  • Povidone
  • Ethyl Acetate
  • D&c Red No. 28
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Ferric Oxide Yellow
  • Gelatin
  • Silicon Dioxide
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Magnesium Stearate
  • Sodium Lauryl Sulfate
  • D&c Red No. 33
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Gelatin
  • Titanium Dioxide

Related Products:

Based on records with the same trade name.
  • 66220-422 Omeclamox-pak Kit by Cumberland Pharmaceuticals Inc.

NDC QR Code

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NDC 65224-707 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.