66993-485 : Zileuton 600 mg Oral Tablet, Extended Release


NDC66993-485
Labeler: Prasco, LLC
Product Type: Human Prescription Drug
Drug Name:  Zileuton
Dosage Form: Oral Tablet, Extended Release
Application #: NDA022052
Rev. Date: 


Appearance:


Markings: CT2
Shapes:  Oval
Colors:  White
Size (mm): 19
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:

  • 66993-485-32: 120 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (66993‑485‑32)

Active Ingredients:

  • Zileuton

Dosage Strength:

  • 600 mg

Inactive Ingredients:

  • Crospovidone
  • Ferric Oxide Red
  • Glyceryl Dibehenate
  • Hydroxypropyl Cellulose (Type H)
  • Hypromelloses
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Corn
  • Propylene Glycol
  • Sodium Starch Glycolate Type a Potato
  • Talc

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 24486-902 Zileuton 600 mg Oral Tablet, Extended Release by Aristos Phamaceuticals, Inc.
  • 31722-044 Zileuton 600 mg Oral Tablet, Film Coated, Extended Release by Camber Pharmaceuticals, Inc.
  • 49884-723 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Par Pharmaceutical, Inc.
  • 51407-741 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Golden State Medical Supply, Inc.
  • 64380-189 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Strides Pharma Science Limited
  • 64980-206 Zileuton 600 mg Oral Tablet, Extended Release by Rising Pharmaceuticals, Inc.
  • 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 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.