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

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


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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Note: The MedsChat® 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.