49884-589 : Accolate 10 mg Oral Tablet, Coated

Labeler: Par Pharmaceutical Inc.
Product Type: Human Prescription Drug
Drug Name:  Accolate
Dosage Form: Oral Tablet, Coated
Application #: NDA020547
Rev. Date: 


Shapes:  Round
Colors:  White
Size (mm): 6
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:

  • 49884-589-02: 60 TABLET, COATED IN 1 BOTTLE (49884‑589‑02)

Active Ingredients:

  • Zafirlukast

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Lactose, Unspecified Form
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidones
  • Hypromelloses
  • Titanium Dioxide

Pharmaceutical Classes:

  • Leukotriene Receptor Antagonists [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Leukotriene Receptor Antagonist [EPC]

Related Products:

Based on records with the same trade name.
  • 49884-010 Accolate 10 mg Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-011 Accolate 20 mg Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-590 Accolate 20 mg Oral Tablet, Coated by Par Pharmaceutical Inc.
  • 0310-0401 Accolate 10 mg Oral Tablet by Astrazeneca Pharmaceuticals Lp
  • 0310-0402 Accolate 20 mg Oral Tablet by Astrazeneca Pharmaceuticals Lp
  • 53808-0203 Accolate 20 mg Oral Tablet by State of Florida Doh Central Pharmacy


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Related Discussions:

Accolate availability
Are there any lower cost substitutes for Accolate? Anyone know when the patent on it runs out? ## I have received no rep... 1 reply

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