58463-002 : Moxatag 775 mg Oral Tablet, Film Coated, Extended Release


NDC58463-002
Labeler: Pragma Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name:  Moxatag
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA050813
Rev. Date: 


Appearance:


Markings: MB;111
Shapes:  Oval
Colors:  Blue
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.

MB 111: (68453-142) Moxatag 775 mg Oral Tablet, Film Coated, Extended Release by Pragma Pharmaceuticals, LLC
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:

  • 58463-002-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (58463‑002‑30)

Active Ingredients:

  • Amoxicillin

Dosage Strength:

  • 775 mg

Inactive Ingredients:

  • Crospovidone
  • Fd&c Blue No. 2
  • Hypromelloses
  • Hypromellose Acetate Succinate 16070722 (3 Mm2/S)
  • Ferric Oxide Red
  • Magnesium Stearate
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 400
  • Polyoxyl 35 Castor Oil
  • Povidone
  • Shellac
  • Colloidal Silicon Dioxide
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate

Pharmaceutical Classes:

  • Penicillin-class Antibacterial [EPC]
  • Penicillins [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 11042-142 Moxatag 775 mg Extended Release Tablet by Middlebrook Pharmaceuticals, Inc.
  • 59630-142 Moxatag 775 mg Extended Release Tablet by Shionogi Inc.
  • 68453-142 Moxatag 775 mg Extended Release Tablet by Victory Pharma, Inc.
  • 69442-030 Moxatag 775 mg Oral Tablet, Film Coated, Extended Release by Vernalis Therapeutics, Inc.

NDC QR Code

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NDC 58463-002 QR Code

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