64980-206 : Zileuton 600 mg Oral Tablet, Extended Release


NDC64980-206
Labeler: Rising Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zileuton
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA204929
Rev. Date: 


Appearance:


Markings: 656;P
Shapes:  Oval
Colors:  Yellow
Size (mm): 20
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:

  • 64980-206-12: 120 TABLET, EXTENDED RELEASE IN 1 BOTTLE (64980‑206‑12)

Active Ingredients:

  • Zileuton

Dosage Strength:

  • 600 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hypromelloses
  • Hypromellose 2910 (6 Mpa.s)
  • Magnesium Stearate
  • Mannitol
  • Microcrystalline Cellulose
  • Starch, Corn
  • Polyethylene Glycol 400
  • Sodium Lauryl Sulfate
  • Sodium Starch Glycolate Type a Corn
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • 5-Lipoxygenase Inhibitor [EPC]
  • 5-Lipoxygenase Inhibitors [MoA]
  • Decreased Leukotriene Production [PE]

Related Products:

Based on records with the same trade name.
  • 24486-902 Zileuton 600 mg Oral Tablet, Extended Release by Aristos Phamaceuticals, Inc.
  • 49884-723 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Par Pharmaceutical, Inc.
  • 66993-485 Zileuton 600 mg Oral Tablet, Extended Release by Prasco, LLC
  • 68180-169 Zileuton 600 1/1 Oral Tablet, Extended Release by Lupin Pharmaceuticals, Inc.
  • 69339-130 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Dash Pharmaceutical LLC

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