68180-169 : Zileuton 600 1/1 Oral Tablet, Extended Release


NDC: 68180-169
Labeler: Lupin Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zileuton
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA211972
Rev. Date: 


Appearance:


Markings: LU;R21
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:

  • 68180-169-07: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68180‑169‑07)
  • 68180-169-16: 120 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68180‑169‑16)
  • 68180-169-26: 180 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68180‑169‑26)

Active Ingredients:

  • Zileuton

Dosage Strength:

  • 600 1/1

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Crospovidone
  • Hydroxypropyl Cellulose (1200000 Wamw)
  • Hypromellose 2208 (15000 Mpa.s)
  • Hypromellose 2910 (15000 Mpa.s)
  • Magnesium Stearate
  • Mannitol
  • Polyethylene Glycol 3350
  • Povidone K30
  • Starch, Corn /

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.
  • 66993-485 Zileuton 600 mg Oral Tablet, Extended Release by Prasco, LLC
  • 69339-130 Zileuton 600 mg Oral Tablet, Multilayer, Extended Release by Dash Pharmaceutical LLC

NDC QR Code

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NDC 68180-169 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.